| CTRI Number |
CTRI/2024/12/078679 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
28/10/2024 |
| 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
|
EFFECT OF PUTIKADI LEPA AND SHVITRAHARA VARTI ALONG WITH SHASHILEKHA VATI IN VITILIGO. |
|
Scientific Title of Study
|
A RANDOMISED CLINICAL TRIAL ON
COMPARATIVE EFFICACY OF PUTIKADI LEPA AND SHVITRAHARA VARTI
COADMINISTERED WITH SHASHILEKHA VATI IN VITILIGO PATIENTS AND
ITS IMPACT ON ALPHA-MSH. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VINAY KUMAR |
| Designation |
MD SCHOLAR |
| Affiliation |
ALL INDIA INSTITUTE OF AYURVEDA, NEW DELHI |
| Address |
ROOM NO 311, 3RD FLOOR,ACADEMIC BLOCK,DEPARTMENT OF ROGA NIDANA EVUM VIKRITI VIGYANA ,ALL INDIA INSTITUTE OF AYURVEDA , GAUTAMPURI,SARITA VIHAR, NEW DELHI 110076
ROOM NO 311, 3RD FLOOR,ACADEMIC BLOCK,DEPARTMENT OF ROGA NIDANA EVUM VIKRITI VIGYANA ,ALL INDIA INSTITUTE OF AYURVEDA , GAUTAMPURI,SARITA VIHAR, NEW DELHI 110076
South
DELHI
110076
India |
| Phone |
9560743062 |
| Fax |
|
| Email |
vinay.bams99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VINAY KUMAR |
| Designation |
MD SCHOLAR |
| Affiliation |
ALL INDIA INSTITUTE OF AYURVEDA, NEW DELHI |
| Address |
ROOM NO 311, 3RD FLOOR,ACADEMIC BLOCK,DEPARTMENT OF ROGA NIDANA EVUM VIKRITI VIGYANA ,ALL INDIA INSTITUTE OF AYURVEDA , GAUTAMPURI,SARITA VIHAR, NEW DELHI 110076
ROOM NO 311, 3RD FLOOR,ACADEMIC BLOCK,DEPARTMENT OF ROGA NIDANA EVUM VIKRITI VIGYANA ,ALL INDIA INSTITUTE OF AYURVEDA , GAUTAMPURI,SARITA VIHAR, NEW DELHI 110076
South
DELHI
110076
India |
| Phone |
9560743062 |
| Fax |
|
| Email |
vinay.bams99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ANAND B MORE |
| Designation |
PROFESSOR OF ROGA NIDANA EVUM VIKRITI VIGYAN |
| Affiliation |
ALL INDIA INSTITUTE OF AYURVEDA |
| Address |
ROOM NO.311,3RD 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
ROOM NO.311,3RD 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 |
9422025732 |
| Fax |
|
| Email |
drmoreanand@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF AYURVEDA, GAUTAM PURI, SARITA VIHAR, NEW DELHI-110076 |
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF AYURVEDA |
| Address |
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 ANAND B MORE |
ALL INDIA INSTITUTE OF AYURVEDA |
OPD NO 16 SCREENING OPD HOSPITAL BLOCK GROUND FLOOR GAUTAMPURIPURI SOUTH DELHI NEW DELHI
South
DELHI |
09422025732
drmoreanand@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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: SHWITRAHARA VARTI, Reference: ASHTANGA HRIDYA CHIKITSA 20/23, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: PUTIKADI LEPA, Reference: SUSHRUTA CHIKITSA 9/40, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
(1) Patients diagnosed with nonsegmental vitiligo with maximum 2 years of disease history.
(2) Patients of age group: 21-45 years of either gender.
(3) Patients willing to participate.
|
|
| ExclusionCriteria |
| Details |
(1) Patients suffering from psychiatric illness.
(2) Pregnant females and lactating women.
(3) Patients suffering from any other Systemic Disorders like uncontrolled diabetes, hepatitis B positive, HIV positive, active case of tuberculosis, immunocompromised patient, kidney disease, other skin disease.
(4) Cases of vitiligo due to burns.
(5) Any allergic condition related to skin and hypersensitivity to any medicine.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvement in shwitra assessed through VETF and VASI score in vitiligo patients. |
0th day and 60th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| change in level of Alpha-MSH at 0th to 60th day in blood samples of vitiligo patients |
0th day to 60th day |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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 |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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="1"
Months="6"
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
|
The clinical efficacy of Sashilekha Vati and Shvitrahar
Varti are
documented in previous studies.
However, no combination study of the two drugs is yet available.The ointment Putikadi Lepa[i] is a classical yoga mentioned in
Sushruta Samhita 940 for Shvitra.No previous study on Putikadi Lepa in relation to Shvitra is yet
available across various research databases, hence this drug was chosen to
compare its effectiveness with Shvitrahar Varti through a
clinical trial of 60 days.
|