| CTRI Number |
CTRI/2020/02/023408 [Registered on: 18/02/2020] Trial Registered Prospectively |
| Last Modified On: |
05/03/2021 |
| 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 see the effect of Dhatryadi lepa as compared to Shalmalikantak lepa in treatment of acne vulgaris. |
|
Scientific Title of Study
|
“Comparative open label randomized clinical study to evaluate efficacy of Dhatrayadi lepa with Shalmalikantak lepa in the management of Mukhadushika (Acne vulgaris)†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyanka Yadav |
| Designation |
MD scholar Kayachikitsa |
| Affiliation |
Dr. Dy patil college of Ayurveda and research center pimpri Pune |
| Address |
Dr.Dy patil college of Ayurveda and research centre pimpri pune 411018.
Kayachikitsa department
Opd number 5
Sant tukaram nagar pimpri colony Pimpri Chinchwad 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
7718015502 |
| Fax |
|
| Email |
priyaay25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gunwant yeola |
| Designation |
HOD Kayachikitsa |
| Affiliation |
Dr Dy patil college of Ayurveda and research center pimpri Pune |
| Address |
Dr. Dy patil college of Ayurveda and research center pimpri pune
Sant tukaram nagar, pimpri colony, Pimpri Chinchwad 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9028321955 |
| Fax |
|
| Email |
gunvantayurved@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Yadav |
| Designation |
MD scholar Kayachikitsa |
| Affiliation |
Dr. Dy patil college of Ayurveda and research center pimpri Pune |
| Address |
Dr. Dy patil college of Ayurveda and research centre pimpri pune 411018
Kayachikitsa department
Opd number 05
Sant tukaram nagar pimpri colony Pimpri Chinchwad 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
7718015502 |
| Fax |
|
| Email |
priyaay25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Dy patil college of Ayurveda and research centre pimpri pune |
|
|
Primary Sponsor
|
| Name |
Dr Priyanka Yadav |
| Address |
Dr Dy Patil college of Ayurveda 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 |
| Priyanka Yadav |
Dr. Dy Patil college of Ayurveda and research centre |
Kayachikitsa OPDand IPD
Dr. Dy Patil college of Ayurveda and research centre, sant tukaram nagar, pimpri, pune, 411018, Maharashtra.
Pune
MAHARASHTRA |
7718015502
priyaay25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Recognition committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patient should be in a good healthy condition. They should not have any hypertensive or diabetic disorder . |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dhatryadi (Lodhra, dhatri, vacha) lepa |
To be applied locally as per requirement daily in the morning.
Duration of the study will be 28 days (0-7th day-14th day-21st day-28th day) |
| Comparator Agent |
Shalmalikantak lepa |
To be applied locally as per requirement daily in the morning.
Duration of the study will be 28 days (0-7th day-14th day-21st day-28th day) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from Acne vulgaris. |
|
| ExclusionCriteria |
| Details |
Patient suffering from other skin diseases.
Patient suffering from Chronic illness and infective diseases like malignant conditions and skin tuberculosis.
Acne produced due to side effect of any drug applied earlier. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To get cured of Acne vulgaris. |
The cure shall be assessed in 4 follow ups in 28 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Getting cured of the marked symptoms on the skin adding to the cosmetic effect. |
28 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
18/02/2020 |
| Date of Study Completion (India) |
31/01/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
No |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The aim of the study is to find the effectiveness of Dhatryadi lepa and shalmalikantak lepa in the management of Acne vulgaris. The study will be conducted in two groups. Group A will be given Dhatryadi lepa. Group B will be given Shalmalikantak lepa. For both the group of patients medicine will be given for 28 days and follow up will be taken and result will be done using proper statistical methods. |