| CTRI Number |
CTRI/2025/09/094747 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
13/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to check if Somraji gel alone or along with Swayambhuva Guggulu helps in reducing white patches on the skin (vitiligo) in children. |
|
Scientific Title of Study
|
Efficacy of Somraji Gel with and Without Swayambhuva Guggulu in Childhood Vitiligo (Svitra): An Open Label Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Geetika Vashishth |
| Designation |
PG Scholar |
| Affiliation |
All India Institute of Aturveda |
| Address |
Room no. 406 Department of Kaumarabhritya 4th floor AIIA Gautampuri Awas Molarband Sarita Vihar Delhi
South
DELHI
110076
India |
| Phone |
7982003732 |
| Fax |
|
| Email |
gehnavats836@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahapatra Arun Kumar |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room no. 409 Department of Kaumarabhritya 4th floor AIIA Gautampuri Awas Molarband Sarita Vihar Delhi
South
DELHI
110076
India |
| Phone |
8506821947 |
| Fax |
|
| Email |
ayuarun@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Geetika Vashishth |
| Designation |
PG Scholar |
| Affiliation |
All India Institute of Aturveda |
| Address |
Room no. 406 Department of Kaumarabhritya 4th floor AIIA Gautampuri Awas Molarband Sarita Vihar Delhi
South
DELHI
110076
India |
| Phone |
7982003732 |
| Fax |
|
| Email |
gehnavats836@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda |
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF AYURVEDA |
| Address |
Gautampuri, Sarita Vihar, Delhi-110076 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Geetika Vashishth |
All India Institute of Ayurveda |
Room no.208 Kaumarabhritya OPD 2nd floor Gautampuri Awas Sarita Vihar
South
DELHI |
7982003732
gehnavats836@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIA Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L80||Vitiligo. Ayurveda Condition: SVITRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Swayambhuva Guggulu , Reference: Bhavaprakash Madhyam Khanda , Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Luke warm water ), Additional Information: -(2) Medicine Name: Somraji gel , Reference: Bhaishajya Ratnavali , Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2.5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -sunlight exposure after gel application for 30 minutes | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Somraji gel , Reference: Bhaishajya Ratnavali , Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2.5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -Sunlight exposure of 30 minutes after gel application in morning |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1.Children of age group 5-16 years of either gender.
2.Woods lamp positive for vitiligo.
3.Patients with Sadhya Lakshana of Svitra (Peeta chavi, Pandu varna, Ruksha).
4.Patients having Svitra patches with normal tactile sensation.
5.Patients with Twak svetata mandatorily, and preferably any or all of Roukshya, Kandu, Daha, Vivarnata (Roma) in the subjective symptom scoring.
6.Patients who are willing to participate in study.
7.Patients having history of steroids or PUVA therapy (after a washout period of 1 month.)
|
|
| ExclusionCriteria |
| Details |
1.Patients not willing to participate in the study, and beyond the age range 5-16 years.
2.Patients with Asadhya Lakshana of Svitra [Raktalom, Hastha-Pada Tal Jatam, Guhyam Jatam(Sex organ), Aushtheshu(Lip), Agnidagdhaja, Janmajata(Hereditary)].
3.Patients currently on other systems of medication or Ayurvedic medication.
4.Vitiligo associated with malignant melanoma, albinism and psoriasis.
5.Patient suffering from other systemic diseases (like bronchial asthma, etc.) & autoimmune disorders (Eg: Celiac disease, Type I Diabetes mellitus, Inflammable Bowel Disease, etc.)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage re-pigmentation in vitiligo patches, as assessed by the Vitiligo Area Scoring Index (VASI), compared between the two groups at baseline and defined follow-up intervals. |
day 0,30,60,90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in subjective symptom scores (e.g., itching, burning, dryness, etc.) over the intervention period, measured through a standardized symptom scoring scale.
|
day 0,60,90 |
Change in melanin index values, as measured by colorimetry, from baseline to the end of the study period.
|
day 0,30,60,90 |
| Improvement in quality of life, assessed using the Dermatology Life Quality Index (DLQI), by comparing baseline and post-treatment scores. |
day 0,60,90 |
| Safety and dermal tolerance of Somraji gel, based on findings from acute dermal toxicity and sensitivity studies conducted during the preclinical phase. |
Pre Clinically |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title:
Efficacy of Somraji Gel with and without Swayambhuva Guggulu in Childhood Vitiligo (Svitra): An Open Label, Randomized Controlled Trial Summary:
Vitiligo (Svitra) is a skin condition that causes white patches due to loss of skin pigment. It is common in children and often leads to social stigma and psychological stress. Modern treatments like steroids and phototherapy have limitations, side effects, and high costs. Ayurveda describes effective remedies, especially Somraji (Bakuchi) and Swayambhuva Guggulu, but these have not been fully tested in children through scientific trials. Before testing in children, the newly prepared Somraji gel will be first checked for safety in animals as per OECD guidelines. Tests include acute dermal toxicity and skin sensitization to see if the gel causes any irritation, allergy, or toxic effect. The results are expected to confirm that the gel form is safer and less irritating than the traditional oil form, with no harmful reactions observed. This ensures the gel is safe to proceed for human clinical use. This study aims to evaluate whether Somraji gel (an improved and safer gel form of Somraji oil) works better alone or in combination with Swayambhuva Guggulu (a classical Ayurvedic internal medicine) for treating childhood vitiligo. A total of 70 children (aged 5–16 years) with vitiligo will be randomly divided into two groups: The treatment will last 8 weeks, with a 4-week follow-up. Outcomes will be measured by: -
Primary outcome: Improvement in pigmentation (Vitiligo Area Scoring Index – VASI). -
Secondary outcomes: Symptom reduction, changes in melanin index (colorimetry), improvement in quality of life (DLQI), and safety profile. If successful, the study may provide a safe, effective, affordable, and user-friendly Ayurvedic protocol for managing childhood vitiligo, reducing reliance on costly or side-effect-prone modern therapies. |