| CTRI Number |
CTRI/2025/07/091770 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effect of two ayurvedic medicines and ayurvedic lepa in the management of melasama. |
|
Scientific Title of Study
|
A Clinico-Comparative
Study To Evaluate The Efficacy Of Varnya Mahakashaya
Ghanvati With Raktachandanadi Lepa And Laghu Manjisthadi
Kwath Ghanvati With Raktachandanadi Lepa In The
Management Of Vyanga With Special Reference To Melasma
|
| 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 Deepak Rathor |
| Designation |
post graduate resident |
| Affiliation |
pt. khushilal sharma govt autonomous ayurveda college and institue bhopal mp |
| Address |
pg department of kayachikitsa pt. khushilal sharma govt autonomous ayurveda college and institue bhopal mp
pg department of kayachikitsa pt. khushilal sharma govt autonomous ayurveda college and institue bhopal mp
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
7773877593 |
| Fax |
|
| Email |
deepakrathor987@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shraddha Sharma |
| Designation |
Lecturer |
| Affiliation |
pt. khushilal sharma govt autonomous ayurveda college and institue bhopal mp |
| Address |
pg department of kayachikitsa pt. khushilal sharma govt autonomous ayurveda college and institue bhopal mp
pg department of kayachikitsa pt. khushilal sharma govt autonomous ayurveda college and institue bhopal mp
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8109352934 |
| Fax |
|
| Email |
drshraddha.sharma@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Rathor |
| Designation |
post graduate resident |
| Affiliation |
pt. khushilal sharma govt autonomous ayurveda college and institue bhopal mp |
| Address |
pg department of kayachikitsa pt. khushilal sharma govt autonomous ayurveda college and institue bhopal mp
pg department of kayachikitsa pt. khushilal sharma govt autonomous ayurveda college and institue bhopal mp
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
7773877593 |
| Fax |
|
| Email |
deepakrathor987@gmail.com |
|
|
Source of Monetary or Material Support
|
| pt. khushilal sharma govt autonomous ayurveda college and institue bhopal mp |
|
|
Primary Sponsor
|
| Name |
pt khushilal sharma govt autonomous ayurveda college and institue bhopal mp |
| Address |
PG department of kayachikitsa pt. khushilal sharma govt autonomous ayurveda college and institue bhopal mp |
| Type of Sponsor |
Government funding agency |
|
|
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 Deepak Rathor |
pt. khushilal sharma govt autonomous ayurveda college and institue bhopal mp |
Room no.221 pg department of kayachikitsa pt. khushilal sharma govt autonomous ayurveda college and institue bhopal mp
Bhopal
MADHYA PRADESH |
07773877593
deepakrathor987@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee pt. khushilal sharma govt autonomous ayurveda college and institue bhopal mp |
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 | Classical | | (1) Medicine Name: Varnya Mahakashaya Ghanvati, Reference: Charak samhita sutra sthana chapter 4, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -mandosha jala), Additional Information: - | | 2 | Intervention Arm | Procedure | - | pralepa, प्रलेप | (Procedure Reference: Kaviraj Atridev Gupta, Ashtang Hridayam, Vidhyotni Hindi Tika Chaukhambha Sanskrit Sansthan Varanasi, Volume-1, Ashtang Hridayam Uttarsthana Sthan, Procedure details: Patient will be advised to clean the face and wipe by a cotton cloth properly. then the finely powdered ingradints are mixed with appropriate amount of pure water and a paste will be prepared. the paste will be applied on the affected area of the face of the patient against the direction of the hair follicles and will be allowed to dry. The lepa will be cleaned by fresh water just before completely get dry.)
(1) Medicine Name: Raktachandanadi lepa, Reference: Astanga Hriday , Route: Topical, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: od, Duration: 30 Days | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Laghu manjisthadi kwath ghanavati, Reference: Mishra BH, Bhavamisra, Bhava prakasha, with vidyotini hindi commentary, published by chaukhamba Sanskrit bhavna, Varanasi. Kustha Rogadhikar , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -mandoshna jala), Additional Information: - | | 4 | Comparator Arm | Procedure | - | pralepa, प्रलेप | (Procedure Reference: Kaviraj Atridev Gupta, Ashtang Hridayam, Vidhyotni Hindi Tika Chaukhambha Sanskrit Sansthan Varanasi, Volume-1, Ashtang Hridayam Uttarsthana Sthan., Procedure details: Patient will be advised to clean the face and wipe by a cotton cloth properly. then the finely powdered ingradints are mixed with appropriate amount of pure water and a paste will be prepared. the paste will be applied on the affected area of the face of the patient against the direction of the hair follicles and will be allowed to dry. The lepa will be cleaned by fresh water just before completely get dry)
(1) Medicine Name: Raktachandanadi lepa, Reference: Astanga hridaya, Route: Topical, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: od, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling the criteria of Vyanga presenting with clinical symptoms of Vyanga
Patient of either sex will be selected irrespective of cast religion occupation habitat etc
Patient who are willing to give written consent for study and photography |
|
| ExclusionCriteria |
| Details |
Patient having other skin disease like Psoriasis Atopic dermatitis SLE Systemic lupus
erythematosus leprosy etc
Pregnant and Lactating Women
Patients with history of any drug allergies
Patient taking steroids or hormonal therapy
Patients who have any Immunocompressive diseases like HIV Cancer
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
It is expected that at the end of the study we would be able to evaluate and compare the
outcome of Varnya Mahakashaya Ghanvati with Raktachandanadi Lepa and Laghu
Manjisthadi kwath ghanvati with Raktachandanadi Lepa in the management of Vyanga |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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 |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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="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
|
It is expected that at the end of the study we would be able to evaluate and compare the
outcome of Varnya Mahakashaya Ghanvati with Raktachandanadi Lepa and Laghu
Manjisthadi kwath ghanvati with Raktachandanadi Lepa in the management of Vyanga |