| CTRI Number |
CTRI/2022/03/040856 [Registered on: 07/03/2022] Trial Registered Prospectively |
| Last Modified On: |
04/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of effect of Vaman with Shalmali kantak lepa and Virechan with Shalmali kantak lepa in Yuvan pidika (pimples) patients |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of Vaman and Virechan alongwith Shalmali kantak lepa in Yuvan pidika w.s.r.to 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 Akhilanath Parida |
| Designation |
Professor |
| Affiliation |
Vaidya Yagya Dutt Sharma PG Ayurvedic College |
| Address |
Department of Panchkarma
Vaidya Yagya Dutt Sharma PG Ayurvedic College, Khurja, Bulandshahar, UP 203131
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
8249162982 |
| Fax |
|
| Email |
tarinitirupati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akhilanath Parida |
| Designation |
Professor |
| Affiliation |
Vaidya Yagya Dutt Sharma PG Ayurvedic College |
| Address |
Department of Panchkarma
Vaidya Yagya Dutt Sharma PG Ayurvedic College, Khurja, Bulandshahar, UP 203131
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
8249162982 |
| Fax |
|
| Email |
tarinitirupati@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akhilanath Parida |
| Designation |
Professor |
| Affiliation |
Vaidya Yagya Dutt Sharma PG Ayurvedic College |
| Address |
Department of Panchkarma
Vaidya Yagya Dutt Sharma PG Ayurvedic College, Khurja, Bulandshahar, UP 203131
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
8249162982 |
| Fax |
|
| Email |
tarinitirupati@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vaidya Yagya Dutt Sharma PG Ayurvedic College Campus, Khurja, Bulandshahar, UP 203131 |
|
|
Primary Sponsor
|
| Name |
Vaidya Yagya Dutt Sharma PG Ayurvedic College Campus |
| Address |
Department of Panchkarma, Vaidya Yagya Dutt Sharma PG Ayurvedic College, Khurja, Bulandshahar, UP 203131 |
| 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 |
| Dr Shweta Bharti |
PLRD Hospital |
Department of Panchkarma, Vaidya Yagya Dutt Sharma PG Ayurvedic College, Khurja, Bulandshahar, UP 203131
Bulandshahar
UTTAR PRADESH |
09917783888
a.sbharti17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vaidya Yagya Dutt Sharma Ayurveda Mahavidyalaya Ethical Committee, Khurja |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L700||Acne vulgaris. Ayurveda Condition: YUVANAPIDAKAÂ (MUKHADUSHIKA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patients with clinical features of Yuvan pidika w.s.r to Acne Vulgaris.
Patients of age group between 17 and 30 years irrespective of sex, religion, socioeconomic status and occupation will be taken.
Patients who are fit for Vaman karma and Virechan karma according to classical texts. |
|
| ExclusionCriteria |
| Details |
Patients having pidika due to other kshudraroga and kustaroga.
Pidika produced due to side effect of any drug applied earlier.
Patients who are contraindicated for Vaman karma and Virechan karma mentioned in classical texts.
Patients suffering from prameha,masurika. |
|
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Method of Generating Random Sequence
|
|
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Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical assessment will be based on both subjective and objective parameters.The results will be classified as completely cured, marked relief, moderate relief,mild relief, unchanged.
|
Day 1
Day 15
Day 30
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Completely cured 100%relief,Marked relief more than 75%relief, Moderate relief 50%-75%relief,Mild relief 25%-50%relief, Unchanged upto 25%relief |
Day30 |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
09/03/2022 |
| 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="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Analysing the effect of Vaman karma followed by use of Shalmali kantak lepa in Yuvan pidika w.s.r. Acne Vulgaris. Analysing the effect of Virechan karma followed by use of Shalmali kantak lepa in Yuvan pidika w.s.r. Acne Vulgaris. Comparing the efficacy of Vaman karma and Virechan karma alongwith Shalmali kantak lepa in Yuvan pidika w.s.r. Acne Vulgaris. |