| CTRI Number |
CTRI/2017/02/007828 [Registered on: 10/02/2017] Trial Registered Retrospectively |
| Last Modified On: |
09/02/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative study on the effect of Vaman Karma with Raktachandanadi lepa and kaishor Guggulu in the management of Yauvan Pidika (Acne Vulgaris) |
|
Scientific Title of Study
|
A Comparative study on the efficacy of Vaman Karma with Raktachandanadi lepa and kaishor Guggulu in the management of Yauvan 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 |
Makwana Krunal Bhagvanjibhai |
| Designation |
PG scholar |
| Affiliation |
Govt Akhandanand ayurvedic college |
| Address |
Govt Akhandanand Ayurved College and Hospital, Bhadra ,Ahmedabad- 380001
Govt Akhandanand Ayurved College and Hospital, Bhadra ,Ahmedabad- 380001
Ahmadabad
GUJARAT
380001
India |
| Phone |
8000643180 |
| Fax |
|
| Email |
doctorkunal91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sweety Ruparel |
| Designation |
Professor |
| Affiliation |
Govt.Akhandanand ayurvedic college |
| Address |
Govt Akhandanand Ayurved College and Hospital, Bhadra ,Ahmedabad- 380001
Govt Akhandanand Ayurved College and Hospital, Bhadra ,Ahmedabad- 380001
Ahmadabad
GUJARAT
380001
India |
| Phone |
9429202048 |
| Fax |
|
| Email |
sweetyruparel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sweety Ruparel |
| Designation |
Professor |
| Affiliation |
Govt.Akhandanand ayurvedic college |
| Address |
Govt Akhandanand Ayurved College and Hospital, Bhadra ,Ahmedabad- 380001
Govt Akhandanand Ayurved College and Hospital, Bhadra ,Ahmedabad- 380001
Ahmadabad
GUJARAT
380001
India |
| Phone |
9429202048 |
| Fax |
|
| Email |
sweetyruparel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Akhandanand Ayurved College and Hospital, Bhadra ,Ahmedabad- 380001 |
|
|
Primary Sponsor
|
| Name |
Govt Akhandanand Ayurved College and Hospital Bhadra Ahmedabad |
| Address |
Room no. 11
OPD of Panchkarma Department
Govt Akhandanand Ayurved College and Hospital Bhadra Ahmedabad 380001 |
| 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 |
| Dr Krunal Makwana |
Govt Akhandanand Ayurved College and Hospital |
Room no 11
Department of Panchkarma
Govt Akhandanand Ayurved College and Hospital, Bhadra ,Ahmedabad- 380001
Ahmadabad
GUJARAT |
8000643180
doctorkunal91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Yauvan Pidika ( Acne vulgaris) , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Efficacy of vaman karma with raktachandanadi lepa and kaishor guggulu in management of yauvan pidika w.s.r. to Acne vulgaris |
GROUP-A 15 patients will be treated with Vaman Karma followed by Shaman Chikitsa with Kaishor Guggulu & Rakta Chandanadi Lepa
Dose and duration:
Vaman karma (medicated emesis)takes 2 weeks
Shaman chikitsa Kaishor Guggulu 4 tab thrice a day with Lukewarm water for 4 weeks and
Rakta Chandanadi Lepa applied with milk or rose water thickness of Lepa 1/4 Angula 2 Times per Day for 4 Weeks |
| Comparator Agent |
Raktachandanadi lepa and Kaishor guggulu |
Group B
Dose and duration
Kaishor guggulu 4 tab thrice a day with lukewarm water for 6 weeks will be given along with local application that is Raktachandanadi lepa applied with milk or rose water thickness of Lepa 1/4 Angula 2 times per day for 6 weeks |
|
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Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1 Vaman Yogya as per Ayurvedic text
2 The person between the age of 16-30 years
3 Having classical signs of Yauvan Pidika like Paka ,Srava, Kandu, Vedana, Daha, Vaivarnyata and also signs of Acne Vulgaris like Comedone, Papules, Pustules, Nodules, Cysts, Abscess
|
|
| ExclusionCriteria |
| Details |
Vaman Ayogya as per Ayurvedic texts
Diseases like Hypertension, Asthma, Heart disease & other systemic disorders which may lead the patient to fatal condition during Vaman karma
Any other skin disease on face
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvement in symptoms of yauvan pidika |
after completion of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in symptoms of yauvan pidika |
After completion of treatment |
|
|
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)
|
25/07/2016 |
| 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) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is randomized parallel group trial in department of Panchkarma OPD at Govt. akhandanand Ayurvedic college and hospital. In this trial selected patients will be randomly selected in two groups that are group A and group B GROUP A 15 patients will be treated with Vaman karma (medicated emesis) followed by Shaman chikitsa ( internal medication) with Kaishor Guggulu and Rakta Chandanadi Lepa (external application) Procedure for vaman karma (approximate 2 weeks) (1) Deepana and Pachana -Trikatu Churna, Dose: 4 to 6 gm. per day · (2) Aabhyantar Snehapan: Pure Go ghrita (Ghee), Dose: 20 - 40 ml starting dose, in Vardhmana Krama ( As per Aatur-Koshtha and Agni ), Anupan: Ushna Jal (3) Vaman karma: aakanthpan with cow milk Madanphali Yoga (Madan Phala-4gm, Vacha-2gm, -Saindhav-1gm) af after completion of vaman procedure patient will be adviced for shansarjana karma according to shudhhi( 3 or 5 or 7 days). Then patient will be given shaman chikitsa under this - 1) Kaishor guggulu: 4 tab thrice a day (each tablet will be of 500 mg) , Anupan: Lukewarm water Duration: 4 weeks after Vaman Karma 2) Rakta chandanadi lepa - applied with milk or rose water, thickness of Lepa:-1/4 Angula as described in Sharangadhar Samhita Duration : 2 Times/Day for 4 weeks after Vaman Karma in group A GROUP-B:-15 patients will be treated with Shamana with Kaishor Guggulu and Rakta Chandanadi Lepa Detail of drug and duration in Group B: 1) Kaishor guggulu: 4 tab thrice a day (each tablet will be of 500 mg) , Anupan: Lukewarm water Duration: 6 weeks after Vaman Karma 2) Rakta chandanadi lepa - applied with milk or rose water, thickness of Lepa:-1/4 Angula as described in Sharangadhar Samhita Duration : 2 Times/Day for 6 weeks in group B
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