| CTRI Number |
CTRI/2021/11/038026 [Registered on: 15/11/2021] Trial Registered Prospectively |
| Last Modified On: |
19/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study held to see the effect of Mukhabhyanga(Face Massage)of Manjisthadi Taila as compared with Manjisthadi lepa in treating vyanga(Melasma) |
|
Scientific Title of Study
|
Randomized Comparative clinical study of Manjisthadi taila Mukhabhyanga(Face Massage)and Manjisthadi Lepa in the management of Vyanga(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 DOLLY KUMARI |
| Designation |
MD Scholar (Panchakarma) |
| Affiliation |
Dr.D.Y.Patil College of Ayurved and Research Centre |
| Address |
Department of panchakarma OPD no:9 Dr.D.Y.Patil College of Ayurved and Research Centre
Sant Tukaram Nagar,Pimpri,Pune-411018
Pune
MAHARASHTRA
411018
India |
| Phone |
7003470166 |
| Fax |
|
| Email |
dollyguriya235@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaishali R Chaudhari |
| Designation |
MD Panchakarma |
| Affiliation |
Dr.D.Y.Patil College of Ayurved and Research Centre |
| Address |
Department of panchakarma OPD no:9 Dr.D.Y.Patil College of Ayurved and Research Centre
Sant Tukaram Nagar,Pimpri,Pune-411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9822964710 |
| Fax |
|
| Email |
vaishalidhandes@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr DOLLY KUMARI |
| Designation |
MD Scholar (Panchakarma) |
| Affiliation |
Dr.D.Y.Patil College of Ayurved and Research Centre |
| Address |
Department of panchakarma OPD no:9 Dr.D.Y.Patil College of Ayurved and Research Centre
Sant Tukaram Nagar,Pimpri,Pune-411018
Pune
MAHARASHTRA
411018
India |
| Phone |
7003470166 |
| Fax |
|
| Email |
dollyguriya235@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D.Y.Patil College of Ayurved and Research centre |
|
|
Primary Sponsor
|
| Name |
Dr DOLLY KUMARI |
| Address |
Department of Panchakarma OPD no:9 Dr. D.Y.Patil College of Ayurved and Research Centre Sant Tukaram nagar Pimpri,Pune-411018 |
| Type of Sponsor |
Other [Self] |
|
|
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 DOLLY KUMARI |
Dr. D.Y.Patil college of ayurved and research centre |
Department of Panchakarma OPD no:9 Dr. D.Y.Patil College of Ayurved and Research Centre Sant Tukaram nagar,Pimpri,Pune-411018
Pune
MAHARASHTRA |
7003470166
dollyguriya235@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:L814||Other melanin hyperpigmentation. Ayurveda Condition: VYANGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | aBya~ggaH, अà¤à¥à¤¯à¤‚ग lepa Pradhan Karma | (Procedure Reference: Yogratnakar samhita, Procedure details: Mukhabhyanga 15 mins/day for 7 days.
Lepa 15 mins/day for 7 days)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having sign and symptoms of Vyanga Niruja(painless),Tanu(thin),Shyava varna(blackish in colour)
Patients with age limit from 18-60 yrs. |
|
| ExclusionCriteria |
| Details |
Patients having any systemic disease like cushing syndrome
Patients having hyper pigmentation since birth like neavous of ota
Patients having tumour like malignant melanoma |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Manjisthadi Taila is as effective as Manjisthadi Lepa in the management of Vyanga(Melasma) |
7 days with two follow up (0, 7, 14 days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Manjisthadi taila is effective in treating Vyanga(Melasma) |
7 days with two follow up (0, 7, 14 days) |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "66"
Final Enrollment numbers achieved (India)="66" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
07/02/2022 |
| Date of Study Completion (India) |
03/04/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
03/04/2023 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Study the effect of Manjisthadi taila Mukhabhyanga on 33 patients comparing with Manjisthadi lepa on rest 33 patients suffering from Vyanga(Melasma). Total 66 patients will be enrolled for a duration of 7 days. |