| CTRI Number |
CTRI/2022/12/048372 [Registered on: 21/12/2022] Trial Registered Prospectively |
| Last Modified On: |
18/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A CNINCAL STUDY TO KNOW THE EFFICACY OF AN AYURVEDIC FORMULATION (TUSHA RAHITA YAVADI CHOORNA LEPA) FOR THE TREATMENT OF VYANGA , MELASMA. |
|
Scientific Title of Study
|
A Randomized Open Label Controlled Clinical Study To Evaluate The Efficacy Of Tusha Rahita Yavadi Choorna Lepa In The Management Of Vyanga With Special Reference to Melasma. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hanika Sharma |
| Designation |
PG Scholar, Dept. of Kayachikitsa |
| Affiliation |
Jammu Institute of Ayurveda and Research |
| Address |
JAMMU INSTITUTE OF AYURVEDA AND RESEARCH, DEPT OF PG STUDIES IN KAYACHIKITSA, KOT BHALWAL ROAD,NARDANI,BAJWAN, JAMMU,JAMMU AND KASHMIR,PIN 181123, INDIA
JAMMU INSTITUTE OF AYURVEDA AND RESEARCH, DEPT OF PG STUDIES IN KAYACHIKITSA, KOT BHALWAL ROAD,NARDANI,BAJWAN, JAMMU,JAMMU AND KASHMIR,PIN 181123, INDIA
Jammu
JAMMU & KASHMIR
181123
India |
| Phone |
7006499688 |
| Fax |
|
| Email |
sharmahanika25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHARADA |
| Designation |
GUIDE |
| Affiliation |
Jammu Institute of Ayurveda and Research |
| Address |
JAMMU INSTITUTE OF AYURVEDA AND RESEARCH, PRINCIPAL OFFICE, JAAMU INATITUTE OF AYURVEDA AND RESEARCH , KOT BHALWAL ROAD,NARDANI,BAJWAN, JAMMU,JAMMU AND KASHMIR,PIN 181123, INDIA
JAMMU INSTITUTE OF AYURVEDA AND RESEARCH, PRINCIPAL OFFICE, JAAMU INATITUTE OF AYURVEDA AND RESEARCH , KOT BHALWAL ROAD,NARDANI,BAJWAN, JAMMU,JAMMU AND KASHMIR,PIN 181123, INDIA
Jammu
JAMMU & KASHMIR
181123
India |
| Phone |
9886540088 |
| Fax |
|
| Email |
susharada@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hanika Sharma |
| Designation |
PG Scholar, Dept. of Kayachikitsa |
| Affiliation |
Jammu Institute of Ayurveda and Research |
| Address |
JAMMU INSTITUTE OF AYURVEDA AND RESEARCH , DEPT OF PG STUDIES IN KAYACHIKITSA, JAAMU INSTITUTE OF AYURVEDA AND RESEARCH , KOT BHALWAL ROAD,NARDANI,BAJWAN, JAMMU,JAMMU AND KASHMIR,PIN 181123, INDIA
JAMMU INSTITUTE OF AYURVEDA AND RESEARCH , DEPT OF PG STUDIES IN KAYACHIKITSA, JAAMU INSTITUTE OF AYURVEDA AND RESEARCH , KOT BHALWAL ROAD,NARDANI,BAJWAN, JAMMU,JAMMU AND KASHMIR,PIN 181123, INDIA
Jammu
JAMMU & KASHMIR
181123
India |
| Phone |
7006499688 |
| Fax |
|
| Email |
sharmahanika25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jammu Institute of Ayurveda And Research |
|
|
Primary Sponsor
|
| Name |
Jammu Institute of Ayurveda and Research Jammu |
| Address |
KOT BHALWAL ROAD, NARDANI, BAJWAN, JAMMU, JAMMU AND KASHMIR,181123 |
| Type of Sponsor |
Other [Private Ayurveda 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 Hanika Sharma |
Jammu Institute of Ayurveda, Jammu |
Room No 102 , 1st floor , Dept of Kayachikitsa JIAR Jammu , Kot Bhalwal Road , Nardani Bajwan, Jammu,Jammu And Kashmir, 181123
Jammu
JAMMU & KASHMIR |
7006499688
sharmahanika25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jammu Institute of Ayurveda and Research, Jammu |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L814||Other melanin hyperpigmentation. Ayurveda Condition: VYANGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Varnyakar lepa | (Procedure Reference: Baishjyaratnavqli, Procedure details: Lepa is applied all over the affected area and washed off when it dries .)
| | 2 | Comparator Arm | Procedure | - | Varnyakar lepa | (Procedure Reference: Bhavprakash, Procedure details: Lepa is applied all over the affected area and washed of with water when it dries)
|
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Willing To Participate, patients with sign and symptoms of vyanga. |
|
| ExclusionCriteria |
| Details |
pregnant,lactating women,diabetese mellitus, hypertension. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
SUBJECTIVE CRITERIA-
Dry skin
Itching
Burning sensation
Oily skin
OBJECTIVE PARAMETERS-
MASI Score |
base line |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Dry Skin
Itching |
0th day, 30th day,45th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/06/2023 |
| Date of Study Completion (India) |
01/11/2023 |
| Date of First Enrollment (Global) |
05/06/2023 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The disease vyanga is mentioned under kshudra rogas which affects the skin and decreases the glowing complexion of face. It is characterised by niruja , tanu and shava varna mandlas. It occurs due to vitiation of vata , pitta dosha along with rakt dhatu. clinical signs and sympyoms of vyanga are similar to melasma , hence vyanga can be co-realted with melasma. Total Duration: 45 days Dose: As required. |