| CTRI Number |
CTRI/2023/04/051426 [Registered on: 10/04/2023] Trial Registered Prospectively |
| Last Modified On: |
04/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Drug
Ayurveda
Other (Specify) [virechana karma] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
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Public Title of Study
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Ayurvedic Management of Vitiligo |
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Scientific Title of Study
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Evaluation of add on-effect of Virechana in the management of Shvitra (vitiligo in children) along with Manjishtadi Kashaya, Siva Gutika and Gandhakadi lepa -An open label randomized comparative clinical study.
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| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr chinmay dhananjay chaudhari |
| Designation |
pg scholar |
| Affiliation |
All India Institute of Ayurveda New Delhi |
| Address |
opd no 208 2nd floor hospital block All India Institute of Ayurveda Gautampuri Sarita Vihar New delhi 110076
Room no. 406 4th floor Academic block block All India Institute of Ayurveda Gautampuri Sarita Vihar New delhi 110076
New Delhi
DELHI
110076
India |
| Phone |
9011173228 |
| Fax |
|
| Email |
chaudharichinu1996@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Prashant Kumar Gupta |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Ayurveda New Delhi |
| Address |
Room no 403 Academic block Department of Kaumarbhritya All India Institute of Ayurveda Gautampuri Sarita Vihar New delhi 110076
New Delhi
DELHI
110076
India |
| Phone |
9990988860 |
| Fax |
|
| Email |
prashantgupta27@gmail.com |
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Details of Contact Person
Public Query
|
| Name |
Dr Prashant Kumar Gupta |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Ayurveda New Delhi |
| Address |
Room no 403 Academic block Department of Kaumarbhritya All India Institute of Ayurveda Gautampuri Sarita Vihar New delhi 110076
New Delhi
DELHI
110076
India |
| Phone |
9990988860 |
| Fax |
|
| Email |
prashantgupta27@gmail.com |
|
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Source of Monetary or Material Support
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| All India Institute of Ayurveda |
|
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Primary Sponsor
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| Name |
All India Institute of Ayurveda New Delhi |
| Address |
All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi 110076 |
| Type of Sponsor |
Research institution and hospital |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chinmay Dhananjay Chaudhari |
All India Institute of Ayurveda New Delhi |
Opd no 208 Hospital Block Department of Kaumarabhritya sarita vihar New Delhi
New Delhi
DELHI |
9011173228
chaudharichinu1996@gmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L80||Vitiligo. Ayurveda Condition: SVITRAH, |
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Intervention / Comparator Agent
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| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: sharangdhar, Procedure details: Purva Karma
• Deepana pachana: Chitrakadi vati 1 tab 2 times a day before food with Lukewarm water for 2 days.
• Snehapana: For Snehapana, Goghrita will select. After attaining appropriate Niramata, Snehapana will be started with Hraseeyasi Matra,
i.e., 30 ml and Arohana Snehapana till Samyak Snigdha Lakshanas are seen. It will be given for 3–7 days.
• Abhyanga and Sweda: The patients were administered Abhyanga and Swedana. For Abhyanga, Balaashwagandhadi taila is use. For Swedana, D)
| | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Manjishtadi Kashaya, Reference: Sa. Sam. Ma. 2/136, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Siva gutika, Reference: A. Sam. Utt. 49/169, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -Luke Warm Water), Additional Information: -(3) Medicine Name: Gandhakadi lepa churna, Reference: ARKD 16/101,102, Route: Topical, Dosage Form: Lepa Churna, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: - |
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Inclusion Criteria
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| Age From |
10.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Children of age group 10-16 years of either gender
Patients with Sadhya Lakshana of Shvitra
Patients having Shvitra patches with normal tactile sensation.
Patients who are willing to participate in study.
|
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| ExclusionCriteria |
| Details |
Patients on any other oral/tropical medication.
Vitiligo associated with malignant melanoma, albinism, and psoriasis.
Patient suffering from other systemic diseases & autoimmune disorders.
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Method of Generating Random Sequence
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Random Number Table |
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Method of Concealment
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An Open list of random numbers |
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Blinding/Masking
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Open Label |
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Primary Outcome
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| Outcome |
TimePoints |
| Reduction in subjective symptoms, Vitiligo Extensive Tensity Index (VETI) score and increase in repigmentation |
1st day
61st day
91st day
|
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Secondary Outcome
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| Outcome |
TimePoints |
| Improvement in Children’s Dermatological Life Quality Index (CDLQI) |
1st day
61st day
91st day |
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Target Sample Size
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Total Sample Size="62"
Sample Size from India="62"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 2/ Phase 3 |
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Date of First Enrollment (India)
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01/05/2023 |
| 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 |
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Estimated Duration of Trial
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Years="0"
Months="2"
Days="0" |
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Recruitment Status of Trial (Global)
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Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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NIL |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
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INTRODUCTION: Vitiligo is a common dermatological disorder of chronic depigmentation which is phenotypically characterized by white macules on the skin caused as a result of the systematic destruction of functional melanocytes. It is reported to have a global prevalence of 1% and an Indian incidence of 0.2 to 8.8%. Its common age of onset is 10 to 30 years. It affects both the genders almost equally, but females show earlier ages of onset, hence their predominance being marked in the childhood vitiligo.The exact etiology of vitiligo is poorly understood and is often considered as a multifactorial disease with a complex pathogenesis encompassing several postulations implicating autoimmune, cytotoxic, biochemical, oxidant–antioxidant, viral, and neural mechanisms for destruction of the melanocyte function in genetically predisposed. It is classified into two classes segmental and non-segmental. There is a probable symmetry in the location of patches in non-segmental type of Vitiligo. This class includes generalized, Universal, Focal, Acrofacial and Mucosal Vitiligo. Latter is static and mostly affects the area of skin attached with dorsal root of spinal cord unilaterally.
OBJECTIVES: PRIMARY: Reduction in subjective symptoms, Vitiligo Extensive Tensity Index (VETI) score and increase in repigmentation among pediatric patients of 10-16 years age group of Shvitra(vitiligo) on giving virechana along with Manjishtadi Kashaya, Siva Gutika and Gandhakadi Lepa and only shamana chikitsa for the duration of 60 days. SECONDARY: Improvement in Children’s Dermatological Life Quality Index (CDLQI) among pediatric patients of 10-16 years age group of Shvitra (vitiligo) on giving virechana along with Manjishtadi Kashaya, Siva Gutika and Gandhakadi Lepa and only shamana chikitsa for the duration of 60 days.
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