| CTRI Number |
CTRI/2025/09/094355 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on the causes and treatment effect of asanadi gana in middle age adults with shvitra (non segmental vitiligo) |
|
Scientific Title of Study
|
An etiopathological assessment and upashayatmaka effect of asanadi gana in middle adulthood shvitra (non segmental vitiligo population) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Geetanjali Meena |
| Designation |
MD Scholar |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
Room No. 311, 3 Floor, Academic block, Department of Roga Nidana Evum Vikriti Vigyan, All India Institute of
Ayurveda,Gautampuri,Sarita vihar,New Delhi 110076
South
DELHI
110076
India
South
DELHI
110076
India |
| Phone |
7290023109 |
| Fax |
|
| Email |
geet290198@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rupashri Nath |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
3rd Floor, Academic Block, Department of Roga Nidana Evum Vikriti Vigyan,
All India Institute of Ayurveda,Gautampuri,Sarita vihar,New Delhi 110076
South
DELHI
110076
India
South
DELHI
110076
India |
| Phone |
06398552356 |
| Fax |
|
| Email |
rups.bams@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geetanjali Meena |
| Designation |
MD Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room No. 311, 3 Floor, Academic block, Department of Roga Nidana Evum Vikriti Vigyan, All India Institute of
Ayurveda,Gautampuri,Sarita vihar,New Delhi 110076
South
DELHI
110076
India
South
DELHI
110076
India |
| Phone |
7290023109 |
| Fax |
|
| Email |
geet290198@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda, New Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi
110076 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Geetanjali Meena |
All India Institute of Ayurveda |
Room no.311, 3rd floor, Academic Block, All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi 110076
South
DELHI
South
DELHI |
7290023109
geet290198@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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: Asanadi Gana , Reference: Ashtanga Hridaya Sutrasthana 15/19-20, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with Shvitra (Non
segmental vitiligo) up to the maximum
chronicity of 5 years based on clinical
signs and symptoms.
2. Patients who are middle adulthood
population (40 to 65 years of age),
irrespective of gender, religion,
occupation, and socioeconomic status.
3. Individuals who are willing to participate
in the study.
4. Individuals willing to give written
informed consent. |
|
| ExclusionCriteria |
| Details |
1. Patients having conditions like Post
inflammatory Hypopigmentation, Morphea,
Leprosy (Pinprick test will be done for DD),
Lichen sclerosis, Pityriasis alba, Leukoderma
due to melanoma, Tinea versicolor, Albinism,
Burn, and Wounds.
2. Patients having uncontrolled Diabetes mellitus,
Hypertension, Hypothyroidism and
Hyperlipidaemia.
3. Pregnant and lactating women.
4. Patient having any other severe systemic
disorders. Carcinoma, Hepatic failure, CKD,
SLE.
5. Patient taking oral corticosteroids.
6. Non-co-operative patients.
7.Patient who was enrolled in different study in
the last 3 months.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To understand the key Nidanas (etiopathological factors) of Shvitra (Non- segmental vitiligo)
among middle-adulthood population using a validated questionnaire- Integrated
Etiopathological Assessment Questionnaire for Shvitra (IEAQS). |
The duration of total study will be 45 days including 4 visits i.e., Day 0, Day 15, Day 30, Day 45 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Clinical effectiveness of Asanadi Gana Kashaya in reducing the extent, severity, and symptomatology of vitiligo lesions, as assessed by standardized outcome measures (e.g.
VETI, VIS-22). |
The duration of total study will be 45 days including 4 visits i.e., Day 0, Day 15, Day 30, Day 45 |
| Evaluation of the Upashayatmaka effect of Asanadi Gana Kashaya on the progression and stability of Shvitra (Non-segmental vitiligo). |
The duration of total study will be 45 days including 4 visits i.e., Day 0, Day 15, Day 30, Day 45 |
Improvement in clinical features including lesion re-pigmentation, number and size of
patches, and associated subjective symptoms (e.g., itching, dryness). |
The duration of total study will be 45 days including 4 visits i.e., Day 0, Day 15, Day 30, Day 45 |
Biochemical assessment of treatment response through pre- and post-intervention levels of
S100B and CD8+ markers as surrogate indicators of autoimmune activity and disease activity. |
The duration of total study will be 45 days including 4 visits i.e., Day 0, Day 15, Day 30, Day 45 |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
01/08/2026 |
| 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="1"
Months="6"
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
|
Brief of the study: Shvitra (Non-segmental vitiligo), though non-lethal, has profound psychological, social, and emotional impacts, often leading to anxiety, low self-esteem, social withdrawal, and even suicidal tendencies due to visible skin lesions and resulting stigma. Ayurveda recognizes Shvitra as a Nidanaarthak Vyadhi, a disease stemming from deep-rooted causes highlighting its multifactorial nature involving genetic, autoimmune, psychological, dietary, and lifestyle factors. Supported by Acharya Charaka’s principle of complex causation, Shvitra’s rising incidence in middle adulthood is linked to modern lifestyle disorders like diabetes, obesity, and hypertension. This study aims to explore these underlying causes in middle-aged individuals to enable holistic, root-cause-oriented management rather than merely addressing symptoms. Assessment criteria: 1. To evaluate the severity of the disease, grading of the clinical signs and symptoms of Shvitra (Non-segmental vitiligo) will be assessed before and after the intervention 2. Vitiligo Extent Tensity Index (VETI) score 20 for vitiligo will be assess before and after intervention. 3. S100B and CD8+ will be evaluated before and after intervention. DIAGNOSTIC CRITERIA : Subjective Criteria: Clinical signs and symptoms of Shvitra (Non-segmental vitiligo) mentioned in classical texts: Ruksha, Aruna, Tamra, Kamalapatravat,Sadaha, Romavidvanshi, Shweta,Ghana, Guru, Sakandu, Number of lesions, Body surface Area (BSA) involved 2. Objective Criteria: Woods lamp Examination
END POINT : Resolution in signs and symptoms of Shvitra (Non-segmental vitiligo) in middle adulthood
population.
|