| CTRI Number |
CTRI/2024/10/075377 [Registered on: 16/10/2024] Trial Registered Prospectively |
| Last Modified On: |
15/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two drugs dhatrikhadir kwatha & vishtailam in patient with vitiligo. |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of dhatrikhadir kwath & vishtailam in management ofswitra w.s.r.to vitiligo |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AJAY PHULWARIA |
| Designation |
PG SCHOLAR |
| Affiliation |
MADAN MOHAN MALVIYA GOVERNMENT AYURVED COLLEGE UDAIPUR RAJASTHAN |
| Address |
Opd no 1 kayachikitsa department Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan
Opd no 1 kayachikitsa department Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan
Udaipur
RAJASTHAN
302015
India |
| Phone |
9782059050 |
| Fax |
|
| Email |
ajayphulwaria@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ajay phulwaria |
| Designation |
Pg scholar |
| Affiliation |
Kayachikitsa department mmm government ayurved college udaipur rajasthan |
| Address |
Kayachikitsa department mmm government ayurved college udaipur rajasthan
Madan mohan malviya government ayurved college rdaipur Rajasthan
Udaipur
RAJASTHAN
302015
India |
| Phone |
9782059050 |
| Fax |
|
| Email |
ajayphulwaria@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ajay phulwaria |
| Designation |
Pg Scholar |
| Affiliation |
Kayachikitsa department |
| Address |
Kayachikitsa department mmm govt. ayu. college udaipur
Kayachikitsa department mmm govt. ayu. college udaipur
Udaipur
RAJASTHAN
302015
India |
| Phone |
9782059050 |
| Fax |
|
| Email |
ajayphulwaria@gmail.com |
|
|
Source of Monetary or Material Support
|
| MMM Govt. Ayurved college Udaipur, Rajasthan pin 313001 |
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malviya Government Ayurved College Udaipur |
| Address |
Madan Mohan Malviya Government Ayurved College Udaipur Rajasthan Pin 313001 |
| 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 Ravi Sharma |
Madan Mohan Malviya Govrnment Ayurved College Udaipur |
PG Department of Kayachikitsa Madan Mohan Malviya Government Ayurved College Udaipur, Rajasthan
Udaipur
RAJASTHAN |
9414419259
rspgkcj2015@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutinal ethics committee mmm govt ayurved college ambamata udaipur raj |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L80||Vitiligo. Ayurveda Condition: TVAGGATAKUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Dhatrikhadira kwatha, Reference: Chakrdatt kustha chikitsa 50/70, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: NA | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vishtailam, Reference: Chakrdatt kustha chikitsa 50/146, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: NA |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients presenting with the symptoms of shwitra roga .
2. Patients who age in between 18-70 year will be selected .
3. Patient with history of switra less than one year.
4. Patient diagnosed as switra on the basis of clinical features mentioned in ayurvedic texts.
5. Patient should be capable of obeying pathya-apathya.
|
|
| ExclusionCriteria |
| Details |
1. Patients below age of 18 years and above 70 years.
2. Children with Albinism were excluded.
3. White anesthetic spots, which are characteristic of leprosy.
4. Patches in genital area are excluded from the study.
5. Vitiligo patches complicated by eczema.
6. Patients with long term steroid and cytotoxic treatment.
7. Patients with evidence of malignancy.
8. Pregnant women & lactating mother.
9. Patients suffering from serious systemic disorders like Cardiac Disorders, Malignant disease, or any life-threatening condition.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| relief in number of patches |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Relief in no. of patches,size of patches, color of skin,o color of hair, dryness, burning, sensation, ITCHING,8. HAIR FALL ON AFFECTED AREA
Changes in Vitiligo Extent Tensity Index (VETI) |
60 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
28/10/2024 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY
OF DHATRIKHADIRA KWATHA & VISHTAILAM IN MANAGEMENT OF SHWITRA
W.S.R. TO VITILIGO there will be three group in the study in Group A randamly selected and clinically diagnosed 20 patient of Shwitra will be given Dhatrikhadir kwatha twice a day, Group B 20 patient of Shwitra will be given locally apply Vishatailam, Group C 20 patient of Shwitra will be givenDhatrikhadir kwatha twice a day & locally apply Vishatailam, both. trial will be conduct for a period of 2 months. follow up of the case will be after every 15 days that is for time during treatment. final assesment will be done after completion of two month course on the basis of subjective objective and laborateral assesment. |