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Effectiveness of Fagopyrum esculentum in atopic dermatitis: A single-arm clinical trial
*Corresponding author: Dr. Abhijit Chakma, Central Council for Research in Homoeopathy, New Delhi, India. dr.abhijit24@gmail.com
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Received: ,
Accepted: ,
How to cite this article: Shail VK, Khadim AI, Kumar N, Kumari M, Chakma A. Effectiveness of Fagopyrum esculentum in atopic dermatitis: A single-arm clinical trial. J Integr Stand Homoeopath. 2025;8:118-26. doi: 10.25259/JISH_31_2025
Abstract
Objectives:
The main objective of this study was to evaluate the usefulness of Fagopyrum esculentum in treating AD.
Material and Methods:
This was an open-label, prospective, single-arm clinical trial conducted on 35 participants with AD treated at the outpatient department of a Government Homoeopathic Medical College and Hospital. Being a single-arm study, all participants received F. esculentum and were assessed over a 3-month treatment period. The AD severity index (ADSI) and the children’s dermatology life quality index (CDLQI) were used as the primary and secondary outcome measures, respectively, and were assessed at baseline and after 3 months. The intention-to-treat (ITT) approach was used for statistical analysis. Data distribution was examined. A non-parametric Wilcoxon signed-rank test and a post hoc parametric paired t-test were used accordingly. P < 0.05 was considered statistically significant.
Results:
Three patients dropped out, and 32 completed the trial. ITT sample (n = 35) was analysed at the end. There were statistically significant reductions in both ADSI score (4.834 ± 2.269–0.840 ± 1.165; mean reduction 3.994, 95% confidence intervals [CI]: 3.27–4.71, P < 0.001) and CDLQI (12.228 ± 3.993–2.771 ± 2.015; mean reduction 9.457, 95% CI: 8.20, 10.71, P < 0.001) over 3 months of treatment.
Conclusion:
The study findings suggest that F. esculentum is beneficial in the treatment of AD as well as improving the quality of life. More randomised controlled trials on this clinical condition are further warranted.
Keywords
Atopic dermatitis
Atopic dermatitis severity index
Children’s dermatology life quality index
Fagopyrum esculentum
Homoeopathy
INTRODUCTION
Atopic dermatitis (AD) is a chronic, inflammatory, non-contagious skin disease that significantly reduces quality of life and consumes substantial medical care resources. It is a complex disease with a wide variety of clinical presentations, mainly characterised by itching of the skin, a distinctive rash shape and distribution, a chronic course of relapses and a personal or familial history of ‘atopic diathesis’.[1] However, the clinical presentation varies significantly based on location and age. It frequently precedes the rash (‘itch that rashes’) and can be more uncomfortable at night. This is followed by inflammatory red to brownish-grey areas with small, raised lumps that may leak fluid and crust over when scratched. Although patches may appear anywhere, the flexural surfaces of the joints – such as the insides of the elbows, knees and ankles – are common areas where patches usually appear.[2] AD affects up to 20% of children and 3% of adults.[3] The World Health Organization’s 11th version of the International Classification of Diseases-11 now places dermatitis and eczema in the same category of illnesses as EA80 and EA8Z.[4]
Earlier, Fagopyrum esculentum was known as ‘heath corn’ when the Mongols introduced it to Central Europe in the 14th century, which originated in Central Asia. Because it prefers poor, sandy soils, it was later called ‘buckwheat’ and was traditionally best produced in the heathlands of Northwest Germany. In India and its neighbouring countries, it is grown in the Kasia Mountains and throughout the Himalayas. Despite the lack of clinical experience with this medication on record in the scientific database, F. esculentum has been extensively tested, and certain of its traits are sufficiently well-marked to be considered characteristics. In 1873, Dr. Dexter Hitchcock was the first person to examine this drug.[5,6] Dr. Clarke has listed several characteristics of this drug, especially the visible pulsation of the carotids and other arteries. Offensiveness distinguishes many excretions. And in skin complaints, there is general and excessive itching with or without eruption, most marked on pubes, pudenda, whiskers and hairy portions of the body with aggravation in the afternoon, 5–7 pm.[6] Dr. Allen discovered that it helps in a variety of skin disorders. Skin of arms and legs has a peculiar red appearance as if it would break out in an eruption, and the itching gets more severe in the evening. Itching eruption all over the body and scratching causes others to appear. Old eruptions may become pustular.[5] Dr. Boericke noted that it causes skin itching, which is relieved by cold bathing but worsens with scratching, touch, or at night. It is especially seen in pruritus senilis, affecting the knees, elbows, and hands.[7]
F. esculentum is one of the first Asian crops to be domesticated in South China around 4,000–5,000 years ago. Southern China exported cultivated buckwheat to other Asian countries, Europe, Africa and North and South America.[8] It was an annual herb with upright stems that were 30–90 cm tall, branching above, and glabrous or papillate on one side, with green or crimson foliage when fully grown. Phlobatannins, tannins, alkaloids, amino acids, anthraquinones and sugars were all present in F. esculentum. According to pharmacological research, F. esculentum exhibits anti-inflammatory, anti-cancer, anti-cardiovascular, hypolipidemic, antigenotoxic, antidiabetic, renoprotective, antibacterial, wound-healing, anti-stress, memory-improving, and photoprotective properties. According to a study, F. esculentum inhibited the release of histamine, prostaglandin D2 and cysteinyl leukotriene in immunoglobulin E (IgE)-sensitised rat basophilic leukemia (RBL)-2H3 cells caused by the antigen (dinitrophenyl [DNP]-[HSA] human serum albumin). Furthermore, it suppressed the expression of histidine decarboxylase 2 (HDC2), cyclooxygenase-2 (COX-2) and 5-lipoxygenase mRNAs in IgE-sensitised RBL-2H3 cells. Additionally, when administered orally, buckwheat grain extract exhibited a significant inhibitory effect on anti-DNP IgE-induced passive cutaneous anaphylaxis.[9] Although there is a paucity of clinical trials, experience with this medicine, various homoeopathic literatures[5-7] support its usage in various clinical conditions, especially in skin-related complaints; thus, the purpose of this study was to evaluate the effectiveness of F. esculentum in treating AD along with effect on quality of life.
MATERIAL AND METHODS
Study design
The study was an open-label, prospective, single-arm, non-controlled clinical trial with a pre-post comparison design, conducted among patients attending the outpatient department of a Government Homoeopathic Medical College and hospital in India. The study protocol was approved by the Institutional Ethical Committee (IEC) (Ref. No. RBTS/ETHICS-72/2023; dated 15 February 2023) and registered prospectively in the Clinical Trials Registry of India (CTRI/2023/04/051615).
Inclusion and exclusion criteria
Patients aged between 6 and 15 years of both sexes, of all socioeconomic conditions, having signs and symptoms of AD; pre-diagnosed cases of AD, whose guardians were willing to participate in the study, were included. Patients with immune-compromised, any systemic illness, psychiatric, other uncontrolled or life-threatening illnesses, substance abuse and/or dependence, undergoing homoeopathic treatment for any chronic disease within the past 6 months and whose guardians did not give consent for participation were excluded from the study.
Ethical approval
The IEC approved to conduct of the study. Before enrolling patients, they were informed about the purpose of the study, potential ethical concerns, benefits, side effects, and the investigator’s contact number (in both English and the local language). Participants were told to report any adverse drug reactions/events immediately to the investigator by the guardians of the patients, either by phone or in person. The study protocol was prepared in accordance with the Declaration of Helsinki[10] on human experimentation and the principles of good clinical practice in India.[11] Before the initiation of the study, necessary approval was obtained from the IEC on 15 February 2023, under Reference No. RBTS/ETHICS-72/2023. It was then registered in the CTRI (CTRI/2023/04/051615).
Intervention
Intervention was planned as administering homoeopathic medicine F. esculentum to each patient in centesimal potencies based on homoeopathic principles. Appropriate repetition was performed at a suitable interval as needed. Each dose consisted of 4–6 globules (No. 30) medicated with a single drop of the F. esculentum, preserved in 90% v/v ethanol. Each dose was to be taken orally on an empty stomach, directly on the tongue. Medicines were obtained from the college pharmacy, which was procured from a GMP-certified company, namely SBL Pvt. Ltd. Each patient enrolled was followed up every 15 days or earlier, as required by the patient.
Outcome assessment
Primary outcome: The AD severity index (ADSI) tool was used to assess changes in pruritus, erythema, exudation, excoriation, and lichenification. This ADSI composite tool uses the sum of five signs and symptoms of AD and is graded on a 4-point scale from none (0) to severe (3) for a maximum severity score of 15. It does not include an assessment of the % body surface area.[12]
Secondary outcome
The children’s dermatology life quality index (CDLQI) tool was used to assess the impact of childhood skin conditions on the quality of life in children aged 4–15 years. CDLQI consists of ten questions that focus on symptoms, feelings, daily activities, leisure, work, school, personal relationships, and treatment. Every question asked relates to the previous week. The user can select one of the following options: ‘not at all’, ‘a little’, ‘a lot’, or ‘very much’. Questions are scored from 0 to 3 and totalled, giving an overall score out of 30. The final score ranges from 0 (no impact on quality of life) to 30 (maximum impairment).[13]
Both outcomes were assessed at baseline (0 months) and after 3 months.
Sample size
A formal sample size calculation could not be performed because no earlier studies described the effect size of open-label observational trials evaluating the efficacy of F. esculentum in the treatment of AD. This was the first exploratory study of its kind. Assuming a medium effect size (d) of 0.5, α = 0.05, and a power of 80% to detect significant intra-group changes, we would have required a sample size of 30. With a provision for a 15% drop-out rate, the target sample size was 35.
Statistical techniques
The intention-to-treat (ITT) approach was followed, meaning that every included patient was included in the final analysis. Series mean values replaced missing values. Baseline descriptive data (categorical and continuous) were presented in terms of absolute values, percentages, means, standard deviations, confidence intervals (CI), and other relevant statistics, as appropriate. Data distribution was examined using histograms, Q-Q plots, the Kolmogorov–Smirnov test, and the Shapiro–Wilk test. Descriptive statistics were used to represent baseline data. Inferential statistics were used in the form of a non-parametric Wilcoxon signed-rank test to compare the ADSI and CDLQI scores obtained at baseline and after 3 months. P < 0.05 were considered statistically significant. No interim and subgroup analyses were done. Statistical calculations were done using the Statistical Package for the Social Sciences-IBM software version 22.[14]
Study procedure
According to the pre-specified inclusion and exclusion criteria, 45 patients with AD were initially screened. Ten patients were excluded due to various reasons, and 35 met the eligibility criteria and were enrolled in the study. Following that, baseline socio-demographic and outcome data were obtained (n = 35). After 3 months of intervention and follow-up, outcome data were recorded again. During treatment, three patients dropped out and 32 completed the trial. As the ITT approach was followed, every included patient entered the final analysis (n = 35).
RESULTS
Study flow: Initially, 45 patients suffering from AD were screened for the study, out of which ten patients were excluded as per exclusion criteria, and the remaining 35 cases fulfilling the inclusion criteria were enrolled. Out of 35 cases, three patients discontinued the treatment and were considered drop-outs [Figure 1].

- Study flow diagram.
Recruitment
Starting from May 2023, follow-up of the last enrolled patient was completed by December 2023.
Baseline data
Seven features were studied: age, sex, socio-economic status, food habits, body mass index, residence, and educational status. The entire baseline socio-demographic characteristic is shown in Table 1.
| S. No. | Variable | Number of patients | Percentage |
|---|---|---|---|
| 1. | Agea | 9.8±2.45 | |
| Age Groupb | |||
| 6 - >9 years | 12 | 34.28 | |
| 9 - >12 years | 15 | 42.85 | |
| 12 - >15 years | 08 | 22.85 | |
| 2. | Sexb | ||
| Male | 22 | 62.85 | |
| Female | 13 | 37.14 | |
| 3. | Food habitb | ||
| Vegetarian | 06 | 17.14 | |
| Non-vegetarian | 29 | 82.85 | |
| 4. | Socio-economic conditionb | ||
| Lower class | 14 | 40 | |
| Middle class | 16 | 45.71 | |
| Higher class | 05 | 14.28 | |
| 5. | Body mass index (BMI)a | 20.29±2.83 | |
| BMI (category-wise distribution)b | |||
| a. Under weight (<18.5) | 12 | 34.28 | |
| b. Normal weight (18.5–24.9) | 21 | 60 | |
| c . Over weight (25–29.9) | 02 | 5.71 | |
| 6. | Residenceb | ||
| Urban | 08 | 22.85 | |
| Rural | 27 | 77.14 | |
| 7. | Educational statusb | ||
| Primary school (1–5) | 25 | 71.42 | |
| Secondary school (6–10thclass) | 10 | 28.57 | |
| a. 6–8thclass | 05 | 14.28 | |
| b. 9–10thClass: | 05 | 14.28 |
Data analysis
Outcomes from 32 patients were completed; however, all enrolled subjects (n = 35) were included in the final analyses.
Data distribution
The data distribution appeared inconclusive based on the histograms, Q-Q plots, Kolmogorov–Smirnov test, and Shapiro–Wilk test [Figures 2-13]. Thus, the first nonparametric Wilcoxon signed-rank test was planned to be performed [Table 2]; if significance was detected, a post hoc parametric paired t-test [Table 3] would be performed.

- Histogram changes of ADSI and CDLQI at baseline. Histogram of ADSI score at baseline skewness (−0.114) and kurtosis (0.840). ADSI: Atopic dermatitis severity index, CDLQI: Children’s dermatology life quality index.

- Histogram changes of ADSI and CDLQI after 3 months. Histogram of ADSI score after 3 months skewness (1.346) and kurtosis (1.131). ADSI: Atopic dermatitis severity index, CDLQI: Children’s dermatology life quality index.

- Histogram changes of ADSI and CDLQI at baseline. Histogram of CDLQI score after 3 months skewness (−2556) and kurtosis (6.092). ADSI: Atopic dermatitis severity index, CDLQI: Children’s dermatology life quality index.

- Histogram changes of ADSI and CDLQI after 3 months. Histogram of CDLQI score after 3 months skewness (0.629) and kurtosis (−0.285). ADSI: Atopic dermatitis severity index, CDLQI: Children’s dermatology life quality index.

- Q-Q plot changes of ADSI and CDLQI at baseline. Q-Q plot of baseline distribution of ADSI score. ADSI: Atopic dermatitis severity index, CDLQI: Children’s dermatology life quality index.

- Q-Q plot changes of ADSI and CDLQI after 3 months. Q-Q plot of ADSI score after 4 months. ADSI: Atopic dermatitis severity index, CDLQI: Children’s dermatology life quality index.

- Q-Q plot changes of ADSI and CDLQI at baseline. Q-Q plot of baseline distribution of CDLQI score. ADSI: Atopic dermatitis severity index, CDLQI: Children’s dermatology life quality index.

- Q-Q plot changes of ADSI and CDLQI after 3 months. Q-Q plot of CDLQI score After 4 months. ADSI: Atopic dermatitis severity index, CDLQI: Children’s dermatology life quality index.

- Boxplot changes of ADSI and CDLQI at baseline. Boxplot of ADSI score at baseline median (4,200), IQR (3.00). ADSI: Atopic dermatitis severity index, CDLQI: Children’s dermatology life quality index. Y axis :Measure: ADSI / CDLQI score

- Boxplot changes of ADSI and CDLQI after 3 months. Boxplot of ADSI score after at baseline median (0.000), IQR (1.60). ADSI: Atopic dermatitis severity index, CDLQI: Children’s dermatology life quality index. Y axis :Measure: ADSI / CDLQI score

- Boxplot changes of ADSI and CDLQI at baseline. Boxplot of CDLQI score at baseline median (13.000), IQR (2.00). ADSI: Atopic dermatitis severity index, CDLQI: Children’s dermatology life quality index. Y axis :Measure: ADSI / CDLQI score

- Boxplot changes of ADSI and CDLQI after 3 months. Boxplot of CDLQI score after 3 months median (2.000), IQR (3.00). ADSI: Atopic dermatitis severity index, CDLQI: Children’s dermatology life quality index. Y axis :Measure: ADSI / CDLQI score
Outcome and estimation
There were significant changes both in the ADSI and CDLQI scores (both P < 0.001) after 3 months of individualised homoeopathic treatment, as detected by the non-parametric Wilcoxon signed-rank test [Table 2]. Post hoc parametric paired t-test also revealed significant changes in both outcomes (both P < 0.001) [Table 3].
| Outcomes | Before treatment median (IQR) | After 3 months treatment median (IQR) | Z-value | P-value (2-tailed) |
|---|---|---|---|---|
| ADSI | 4.200 (3.00) | 0.000 (1.60) | −4.947 | 0.000 |
| CDLQI | 13.000 (2.00) | 3.000 (2.00) | −4.950 | 0.000 |
ADSI: Atopic dermatitis severity index; CDLQI: Children dermatology life quality index, IQR: Interquartile range, P-value was calculated using the Wilcoxon signed-rank test, with values<0.05 considered statistically significant. Z-value based on positive ranks
| Outcomes | Before treatment mean±SD | After 3 months treatment mean±SD | Change: mean±SD | 95% CI | t34 | P-value (2-tailed) |
|---|---|---|---|---|---|---|
| ADSI | 4.834±2.269 | 0.840±1.165 | 3.994±2.095 | 3.27, 4.71 | 11.276 | 0.000 |
| CDLQI | 12.228±3.993 | 2.771±2.015 | 9.457±3.656 | 8.20, 10.71 | 15.300 | 0.000 |
CI: Confidence interval; SD: Standard deviation; t34: t score at 34° of freedom; ADSI: Atopic dermatitis severity index, CDLQI: Children’s dermatology life quality index. P-value calculated by paired t-tests;P<0.05 considered as statistically significant
Adverse events
Patients were advised to report any negative effects, unexpected side effects, severe drug adverse events and excessive irritation either directly in the outpatient department or over the phone during the study period. No significant negative event was observed during the whole trial, and the drug was found to be safe for use. One case of minor injury was recorded that was resolved with Arnica Montana. Two cases of acute diarrhoea improved with the use of Pulsatilla nigricans and Nux vomica were also noted.
DISCUSSION
This open-label, prospective, one-arm, non-controlled clinical trial of pre-post comparison was conducted to assess the effectiveness of F. esculentum in treating AD. We searched major databases, including PubMed, Google Scholar, Scopus, ScienceDirect, and Web of Science, and were unable to find a significant number of conclusive, evidence-based clinical trials on the use of F. esculentum in AD. As a result, we planned to carry out this clinical trial on F. esculentum in AD. The study enrolled 35 participants, of whom three dropped out. However, all enrolled patients (n = 35) were included in the final analysis using the ITT approach. The F. esculentum was administered to each participant. ADSI and CDLQI were used as primary and secondary outcome measures, respectively, and were measured at baseline and after 3 months. Both outcomes show statistically significant results (P < 0.0001, 95% CI).
Strengths of the study
The methodological strengths of the study include prospective patient enrolment and the use of standardised and already validated outcome scales, namely ADSI and CDLQI. The study was unambiguous in its protocol declaration, ethical conduct and reporting. Before enrolling, each patient and guardian was made aware of the study’s aims and objectives, methodology, risks and benefits, as well as participation and confidentiality issues (in both English and local languages). Following this, written informed consent was obtained from each participant. Thus, the study met all feasible ethical standards. The IEC has given clearance, and the study is registered in CTRI. Every patient was treated with F. esculentum, and all acquired data (hard form) was turned into an analysable and reproducible master chart (soft copy), from which all data were retrieved methodically and later statistically analysed.
Weaknesses of the study
The study has certain limitations, including a small sample size, a short follow-up duration, the absence of a control or placebo group, and issues with randomisation and blinding. Without a comparator, it is difficult to conclude that the improvement was solely due to F. esculentum and not due to natural remission, the placebo effect, or other factors. Due to the limited study period, the observed improvement reflects only short-term outcomes and cannot confirm long-term benefits or sustained remission. As an observational open-label trial, causal conclusions cannot be drawn, and the potential influence of placebo effects or natural disease fluctuation cannot be excluded. A larger sample drawn from diverse demographic groups with extended follow-up would likely yield more robust and generalizable results.
Strengths and weaknesses of other studies
A double-blind, randomised, placebo-controlled trial was done in a homoeopathy hospital, and the results revealed no significant effect of homoeopathy in AD.[15] However, in double-blind, randomised controlled trials (RCTs), individualised homoeopathic medicines (IHMs) versus placebo plus standard supportive skin care, there was a statistically significant improvement in PO-SCORAD favouring homoeopathy.[16] In another observational study, homoeopathy was found to be effective for individuals with AD, with sulphur accounting for 60% of cases with a positive treatment response.[17] In a non-randomised prospective multicentre open comparative observational study conducted from January 2005 to June 2006 in Berlin, Germany, the study result was unable to rule out residual confounding but taking patient preferences into account, treatment at homoeopathic doctors was similar, yet not superior to treatment at conventional doctors for children with mild to moderate atopic eczema, but still had higher costs.[18] Our study findings also corroborate the findings of RCTs favouring homoeopathy in AD. Thus, considering published documents and supporting the aforementioned statement, future research on the range of homoeopathic remedies is possible and randomised controlled trials with comprehensive methodological rigour are required.
Future perspectives
Future research should include randomised controlled trials with larger, more diverse samples, longer follow-up durations and rigorous methodology to establish causal inferences. Comparative studies between F. esculentum and other commonly indicated homoeopathic remedies could help clarify its relative effectiveness. Integrating patient-reported outcomes and health economics analysis would help to understand its clinical usefulness and cost-effectiveness better.
CONCLUSION
The study finding is suggestive of a positive response of F. esculentum in the treatment of AD among children. The study also highlights that the medicine also improves the quality of life among those suffering from AD. Randomised controlled trials with rigorous methodology are further warranted.
Ethical approval:
The research/study approved by the Institutional Review Board at R.B.T.S. Government Homoeopathic Medical College and Hospital, Muzaffarpur, number RBTS/ETHICS-72/2023, dated 15th February 2023 and registered prospectively in the Clinical Trials Registry of India (CTRI/2023/04/051615).
Declaration of patient consent:
The authors certify that they have obtained all appropriate patient consent.
Conflicts of interest:
There are no conflicts of interest.
Use of artificial intelligence (AI)-assisted technology for manuscript preparation:
The authors confirm that there was no use of artificial intelligence (AI)-assisted technology for assisting in the writing or editing of the manuscript and no images were manipulated using AI.
Financial support and sponsorship: Nil.
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