| CTRI Number |
CTRI/2019/06/019595 [Registered on: 10/06/2019] Trial Registered Prospectively |
| Last Modified On: |
06/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Shalmalikantaka Lepa and Raktachandanadi Lepa along with Kaishor Guggulu on Yauvanpidika |
|
Scientific Title of Study
|
A comparative study on Yauvanpidika(Acne Vulgaris) with management by Shalmalikantaka Lepa and Raktachandanadi Lepa along with Kaishor Guggulu |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Binal D Gondalia |
| Designation |
PG Scholar |
| Affiliation |
Govt Akhandanand Ayurved College |
| Address |
Room No 9 Kayachikitsa Department Govt Akhandanand Ayurved College Bhadra Ahmedabad
Ahmadabad
GUJARAT
380001
India |
| Phone |
9925027291 |
| Fax |
|
| Email |
binalgondalia2010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mustak N Shaikh |
| Designation |
Associate Professor |
| Affiliation |
Govt Akhandanand Ayurved College |
| Address |
Room No 9 Kayachikitsa Department
Govt Akhandanand Ayurved College Bhadra Ahmedabad
Ahmadabad
GUJARAT
380001
India |
| Phone |
9824440708 |
| Fax |
|
| Email |
shaikhmustak542@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Binal D Gondalia |
| Designation |
PG Scholar |
| Affiliation |
Govt Akhandanand Ayurved College |
| Address |
Room No 9 Kayachikitsa Department
Govt Akhandanand Ayurved College Bhadra Ahmedabad
Ahmadabad
GUJARAT
380001
India |
| Phone |
9925027291 |
| Fax |
|
| Email |
binalgondalia2010@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Govt Akhandanand Ayurved College |
| Address |
Govt Akhandanand Ayurved College Bhadra Ahmedabad |
| 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 |
| Binal D Gondalia |
Govt Akhandanand Ayurved College Ahmedabad |
Room No 9 Kayachikitsa Department Govt Akhandanand Ayurved College Bhadra Ahmedabad
Ahmadabad
GUJARAT |
9925027291
binalgondalia2010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L700||Acne vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Kaishor Guggulu and Raktachandanadi Lepa |
15 patients wil be taken in group B and Kaishor Guggulu will be prepared as described in Sharangdhara Samhita Guggulu Kalpana and patients will be treated in following dose and duration Dose 3 tablets thrice a day each tablet is 500 mg with Khadir sidhha jala 20 ml for 4 weeks
Raktachandanadi Lepa will be prepared as described in Sharangdhara Samhita Dose 20 gm per day apply with milk Administration local application on affected area Duration 4 weeks
Single sitting duration Lepa will be remove before it becomes 70% dry |
| Intervention |
Kaishor Guggulu and Shalmalikantaka Lepa |
15 patients will be taken in group A and Kaishor Guggulu will be prepared as described in Sharangdhara Samhita Guggulu Kalpana and will be treated in following dose and duration Dose 3 tablets thrice a day each tablet is 500 mg with Khadir sidhha jala 20 ml for 4 weeks
Shalmalikantaka Lepa will be prepared as described in Sharangdhara Samhita Dose 20 gm per day apply with milk Administration local application on affected area Duration 4 weeks
single sitting duration Lepa will be remove before it becomes 70% dry |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
32.00 Year(s) |
| Gender |
Both |
| Details |
Classical sign and symptoms of Yauvanpidika like Paka Strava Kandu Vedana and Daha |
|
| ExclusionCriteria |
| Details |
Any pidika due to systemic disease like Prameha pidika Masurika
cancer AIDS STD TB and other disorder which lead to fatal condition for patients
Female with pathological involvement sex hormones like primary infertility Hormone replacement therapy Taking OCP will be excluded |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Result will be assessed on the basis of sign and symptoms Yauvanpidika |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
14/06/2019 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To study the efficacy of Shalmalikantaka Lepa and Raktachandanadi Lepa along with Kaishor Guggulu in the management of Yauvanpidika This study is Randomized Controlled Open Lable Parallel Group Trial |