| CTRI Number |
CTRI/2021/07/035085 [Registered on: 23/07/2021] Trial Registered Prospectively |
| Last Modified On: |
22/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Etiopathology study of Shvitra(Vitiligo) and Therapeutic uses of Dhatri Khadiradi Yog |
|
Scientific Title of Study
|
Etiopathology study of Shvitra(Vitiligo) and Therapeutic uses of Dhatri Khadiradi Yog |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Zeiba Khan |
| Designation |
MD Scholar of Rog nidan |
| Affiliation |
Madan mohan malviya govt ayurved college |
| Address |
PG department of rog nidan madan mohan malviya govt ayurved college udaipur
PG department of rog nidan madan mohan malviya govt ayurved college udaipur
Udaipur
RAJASTHAN
313004
India |
| Phone |
6378265546 |
| Fax |
|
| Email |
zebak841@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Pankaj Marolia |
| Designation |
Professor and Head of Department |
| Affiliation |
Madan mohan malviya govt ayurved college |
| Address |
PG department of rog nidan madan mohan malviya govt ayurved college udaipur
PG department of rog nidan madan mohan malviya govt ayurved college udaipur
Udaipur
RAJASTHAN
313004
India |
| Phone |
9413193101 |
| Fax |
|
| Email |
pankajmarolia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Zeiba Khan |
| Designation |
MD Scholar of Rog Nidan |
| Affiliation |
Madan mohan malviya govt ayurved college |
| Address |
PG department of rog nidan madan mohan malviya govt ayurved college udaipur
PG department of rog nidan madan mohan malviya govt ayurved college udaipur
Udaipur
RAJASTHAN
313004
India |
| Phone |
6378265546 |
| Fax |
|
| Email |
zebak841@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madan mohan malviya govt ayurveda college udaipur |
|
|
Primary Sponsor
|
| Name |
Madan mohan malviya govt ayurved college |
| Address |
Madan mohan malviya govt ayurveda college udaipur ambamata 313004 |
| 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 Zeiba Khan |
Madan mohan malviya govt ayurved college |
PG department of rog nidan madan mohan malviya govt ayurved college udaipur
Udaipur
RAJASTHAN |
6378265546
zebak841@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MMM Govt Ayurved College Ambamata Udaipur |
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
|
| Type |
Name |
Details |
| Intervention |
Dhatri khadiradi yog |
Dhatri khadiradi yog with bakuchi 30ml twice in a day after meal for 20 days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Pateint willing to give consent for clinical trail.
2.Pateint having any clinical sign and symptoms of Shivitra(vitiligo)
3.Pateint having chronicity less than 5years. |
|
| ExclusionCriteria |
| Details |
1.Patient with age group of less than 18 years and more than 60 years.
2.White anesthetic spots, which are characteristic of leprosy.
3.Patches in genital area will be excluded from the study.
4.Vitiligo patches complicated with eczema.
5.Patients with evidence of malignancy, diabetes mellitus with complication,
albinism.
6.Pregnant women and lactating mother.
7.Patient participated in any clinical trial within last six months. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| changes in sign and symptoms of shvitra(vitiligo). |
60 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in shvitra (vitiligo) grading score. |
60 Days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3 |
|
Date of First Enrollment (India)
|
01/08/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Introduction:- shvitra(vitiligo) is an acquired skin disorder caused by the disappearance of pigment cells from the epidermis that gives rise to well defined white patches which are often symmetrically distributed.The lack of melanin pigment makes the lesional skin more sensitive to sunburn. Aims And Objectives:- 1.To study the etiopathology,symptomatology & progress of the disease as per Ayurveda and modern science. 2.To assess the efficasy of Dhatri Khadiradi Yog with Bakuchi Churna in the management of shvitra. 3.To find safe and effective remedy for this disease. Need Of The Study:- 1.Vitiligo Global Issues Consensus Conference(VGICC) recently revised the classification of the disease.There are still several unmute needs as pathophysiology or prognosis based classification would be more useful. 2.Skin is a largest organ of our body.Equally distribution of color over the body is important to look beautiful. 3.Skin is a mirror that reflects external and internal pathology,and thus helps in diagnosis of disease Study drug:-Dhatri khadiradi yog (Bhaisjya Ratnavali 54/54)
|