| CTRI Number |
CTRI/2024/09/074382 [Registered on: 25/09/2024] Trial Registered Prospectively |
| Last Modified On: |
01/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical trial of classical formulation Manjishthadi tail and its new dosage form gel in Melasma and hyperpigmentaion on face |
|
Scientific Title of Study
|
A comparative pharmaceutical analytical and clinical study of manjishthadi tail and its neo form (gel) by using herbal ingredients of manjishthadi tail with special reference to vyanga |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vaishnavi Gautam |
| Designation |
MD Scholar rasshastra evam bhaisajya kalpana department |
| Affiliation |
Government Ayurvedic College , varanasi |
| Address |
Government ayurvedic college
Chaukaghat , Varanasi
Varanasi
UTTAR PRADESH
221001
India |
| Phone |
7007107668 |
| Fax |
|
| Email |
vaishnavigautam40366@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Sanjay Kumar Pandey |
| Designation |
Professor |
| Affiliation |
Government Ayurvedic College , Varanasi |
| Address |
Department of Ras Shastra and Bhaisajya Kalpana
Government ayurvedic college
Chaukaghat , Varanasi
Rajkiya ayurvedic college
Chaukaghat
Varanasi
UTTAR PRADESH
221001
India |
| Phone |
9417077401 |
| Fax |
|
| Email |
dr.spandey2007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Richa Pathak |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurvedic College , Varanasi |
| Address |
Department of Ras Shastra and Bhaisajya Kalpana
Government ayurvedic college
Chaukaghat , Varanasi
Varanasi
UTTAR PRADESH
221001
India |
| Phone |
8948883359 |
| Fax |
|
| Email |
richapathak384@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College , Chaukaghat , Varanasi, Uttar Pradesh ,India, 221001 |
|
|
Primary Sponsor
|
| Name |
Government Ayurvedic College , Chaukaghat , Varanasi |
| Address |
Government Ayurvedic College , Chaukaghat , Varanasi |
| 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 Vaishnavi Gautam |
Government Ayurvedic College & Hospital Chaukaghat , Varanasi |
OPD no.5 Department of Ras Shastra and Bhaisajya Kalpana
OPD no.20 Department of Swasthvritta and Kayachikitsa
Varanasi
UTTAR PRADESH |
7007107668
vaishnavigautam40366@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee Government Ayurvedic College & Hospital Chaukaghat ,Varanasi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L819||Disorder of pigmentation, unspecified. Ayurveda Condition: VYANGAH, (2) ICD-10 Condition:L818||Other specified disorders of pigmentation. 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: Advanced form of manjishthadi taila (gel), Reference: NA, Route: Topical, Dosage Form: Sprays, Dose: 125(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: No, Additional Information: -it is used as a local application in the form of gel on face | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Manjishthadi taila , Reference: Chakradutta 55/60-62, Route: Topical, Dosage Form: Taila, Dose: 3(drops), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Weeks, anupAna/sahapAna: No, Additional Information: Take 3 drops of oil and apply locally on the face |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Dark brown pigmentation of the facial skin
2. circumscribe patches over facial skin
3. unelevated pigmentation of the facial skin
4. painless patches |
|
| ExclusionCriteria |
| Details |
patients below 15 yrs and above 45 yrs
patients having pigmentation other than face
pigmentation due to any other drug side effect
patients on medication of harmonal therepy
patient having complain of painfull pigmented patches
individual suffering from systemic pathologies like SLE , cancre , several harmonal imbalance , several skin infection and allergies. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| size of patches is decreased |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| decresed in dark brown colour of patches |
8 weeks |
|
|
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 2 |
|
Date of First Enrollment (India)
|
10/10/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
Modification(s)
|
Interventional study
Patients having complaints of facial pigmentation (Vyanga) will be selected from the OPD of Government Ayurvedic College & Hospital Chaukaghat , Varanasi
Total patients = 60
Treatment plan -
Group A - 30 Patients will be treated with local application of Traditional Manjishthadi tail. Group B - 30 Patients will be treated with advanced dosage form of Manjishthadi tail (GEL) by using herbal ingredients of Manjishthadi tail .
Follow up - 7 days |