| CTRI Number |
CTRI/2022/11/047667 [Registered on: 25/11/2022] Trial Registered Prospectively |
| Last Modified On: |
24/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effect of 2 formulations, mukha kantikara gel prepared by powder and its extract in patient with hyperpigmentation |
|
Scientific Title of Study
|
A COMPARATIVE PHARMACO- ANALYTICAL STUDY AND THEIR CLINICAL EVALUATION OF MUKHAKANTIKARA GEL PREPARED BY CHURNA AND EXTRACTS IN VYANGA W S R TO FACIAL MELANOSIS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mamatha K |
| Designation |
2nd year PG scholar |
| Affiliation |
govt ayurvedic medical college bangalore |
| Address |
Dept of rasashsta & bhaishajya kalpana Govt ayurvedic medical college Dhanvantari road.
Bangalore
KARNATAKA
560010
India |
| Phone |
8660889388 |
| Fax |
|
| Email |
mamathanaik388@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamatha K |
| Designation |
2nd year PG scholar |
| Affiliation |
govt ayurvedic medical college bangalore |
| Address |
Dept of rasashsta & bhaishajya kalpana Govt ayurvedic medical college Dhanvantari road.
Bangalore
KARNATAKA
560010
India |
| Phone |
8660889388 |
| Fax |
|
| Email |
mamathanaik388@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Surekha S Medikeri |
| Designation |
Professor and HOD |
| Affiliation |
govt ayurvedic medical college bangalore |
| Address |
Dept of rasashsta & bhaishajya kalpana Govt ayurvedic medical college Dhanvantari road.
Bangalore
KARNATAKA
560010
India |
| Phone |
9449134112 |
| Fax |
|
| Email |
surekhamedikeri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt ayurvedic medical college and hospital, dhanvatari road megistic 560010 karmataka india
email id principalgamc9@gmail.com |
|
|
Primary Sponsor
|
| Name |
govt ayurvedic medical college and hospital |
| Address |
dhanvantari road megistic 560010 Karnataka India |
| 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 Mamatha K |
Govt ayurvedic medical college and hospital |
Room Number 7D
Bangalore
KARNATAKA |
8660889388
mamathanaik388@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L811||Chloasma. Ayurveda Condition: VYANGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: mukhakantikara gel, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(NA), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: dose depend on area involved |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
patients with clinical signs of vyanga as per ayurvedic classics will be included.
chronicity less than 5 years. |
|
| ExclusionCriteria |
| Details |
inflammatory pigmentation
hyperpigmentation caused by tumor like malignant melanoma.
hyperpigmentation caused by acne vulgaris.
hyperpigmentation caused due to systemic diseases.
hyperpigmentation since birth.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvment in MASI scale |
follow up on 45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvent in pigmentation |
on 45th day |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/12/2022 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
this study is randamized, double blind, parallel group trail comparing the safety and efficacy of mukhakantikara gel prepared by churna and extracts in 40 patients with hyperpigmentation that will be conducted in our institute hospital in india, the primary ontcome of measures will be improvement on MASI scale on 45th day. |