| CTRI Number |
CTRI/2021/08/035348 [Registered on: 03/08/2021] Trial Registered Prospectively |
| Last Modified On: |
02/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To find effect of Vagbhatokta varnya lepa in discolouration of facial skin. |
|
Scientific Title of Study
|
RANDOMISED OPEN CONTROLLED CLINICAL STUDY OF VAGBHATOKTA VARNYA LEPA IN VYANGA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivprasad Vitthalrao Gore |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurved Mahavidyalaya,Kodoli |
| Address |
Department of Ayurved Samhita Evam Siddhant,
Yashwant Ayurved Mahavidyalaya,Kodoli
Tal-Panhala,
Dist KOlhapur
Pin-416114
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8329177646 |
| Fax |
|
| Email |
gore.shivprasad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachin Sadashiv Waghmare |
| Designation |
Professor,Ayurved Samhita Evam Siddhant Department,YAM,Kodoli |
| Affiliation |
Yashwant Ayurved Mahavidyalaya,Kodoli |
| Address |
Department of Ayurved Samhita Evam Siddhant,
Yashwant Ayurved Mahavidyalaya,Kodoli
Tal-Panhala,
Dist KOlhapur
Pin-416114
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9822472010 |
| Fax |
|
| Email |
swwaghmaresachin@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sachin Sadashiv Waghmare |
| Designation |
Professor,Ayurved Samhita Evam Siddhant Department,YAM,Kodoli |
| Affiliation |
Yashwant Ayurved Mahavidyalaya,Kodoli |
| Address |
Department of Ayurved Samhita Evam Siddhant,
Yashwant Ayurved Mahavidyalaya,Kodoli
Tal-Panhala,
Dist KOlhapur
Pin-416114
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9822472010 |
| Fax |
|
| Email |
swwaghmaresachin@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurved Mahavidyalaya,Kodoli
Tal PanhalDist Kolhapur
|
|
|
Primary Sponsor
|
| Name |
Yashavant Ayurved MahavidyalayaKodoli Kolhapur |
| Address |
Yashavant Ayurved Mahavidyalaya Kodoli
Tal Panhala
Dist Kolhapur |
| Type of Sponsor |
Private 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 |
| Vd Shivprasad Vitthalrao Gore |
Yashwant Ayurved Mahavidyalaya,Kodoli |
OPD no 17,
Kayachikitsa OPD,
Yashwant Ayurved Mahavidyalaya,Kodoli
Tal-Panhala
Dist-Kolhapur
Kolhapur
MAHARASHTRA |
8329177646
gore.shivprasad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMITTEE |
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 | - | Lepa | (Procedure Reference: Vagbhat Samhita, Procedure details: Lepa churna is mixed with Dugdha and then applied on skin,once a day)
(1) Medicine Name: Jeerakadi Lepa, Reference: Vagbhat Samhita, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: od, Duration: 30 Days | | 2 | Comparator Arm | Procedure | - | Lepa | (Procedure Reference: Yogratnakar, Procedure details: Lepa churna is mixed with honey and then applied on skin,once a day)
(1) Medicine Name: Arjuntwagadi Lepa, Reference: Yogratnakar, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: od, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with classical signs and symptoms of vyanga
Patients from both genders are included
Patients from age group 20 yrs to 60 yrs are included |
|
| ExclusionCriteria |
| Details |
Other systemic disorders
Hyperpigmentation since birth
Malignant melanoma
Female patients having history of long term use of oral contraceptives pills |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To observe and document the effect of Jeerakadi Varnya Lepa in Vyanga
|
Assessment after 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To observe and document the comparative
effect of Jeerakadi Varnya Lepa and Arjuntwagadi Lepa in Vyanga
2. To find out side effects of Jeerakadi Varnya Lepa lepa |
Assessment after 15 days |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
05/08/2021 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The current study is randomised controlled clinical trial, comparing the effect of Jeerakadi Varnya Lepa and Arjuntwagadi Lepa in Vyanga. Pathyapathy a charts will be advised to both the groups. After giving treatment patients will be observed for next 1 month. Jeerakadi Varnya Lepa is mentioned in Vagbhat Samhita. The contents are very easy to available.All the contents are Kaphavataghna and pachak which are very helpful in treating Vyanga. |