| CTRI Number |
CTRI/2025/01/079726 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
25/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurvedic trial for reducing the severity of acne. |
|
Scientific Title of Study
|
A Comparative study to evaluate the efficacy of Amalaki kashay and Varun kashay mukhprakshalana in reducing the severity of Yuvana pidika as a dinacharya procedure- A Randomized Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swati koshatwar |
| Designation |
PG Scholar department of swasthavritta |
| Affiliation |
chaudhary brahm prakash ayurved charak sansthan khera dabar najafgarh new delhi |
| Address |
Room no 222 PG deptartment of Swasthavritta chaudhary brahm prakash ayurved charak sansthan khera dabar najafgarh new delhi
South West
DELHI
110073
India |
| Phone |
8806390851 |
| Fax |
|
| Email |
koshatwarswati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jai Singh Yadav |
| Designation |
Assistant Professor |
| Affiliation |
chaudhary brahm prakash ayurved charak sansthan khera dabar najafgarh new delhi |
| Address |
Room no 230 PG deptartment of Swasthavritta chaudhary brahm prakash ayurved charak sansthan khera dabar najafgarh new delhi
South West
DELHI
110073
India |
| Phone |
7568730726 |
| Fax |
|
| Email |
dr_jaisinghyadav@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jai Singh Yadav |
| Designation |
Assistant Professor |
| Affiliation |
chaudhary brahm prakash ayurved charak sansthan khera dabar najafgarh new delhi |
| Address |
Room no 230 PG deptartment of Swasthavritta chaudhary brahm prakash ayurved charak sansthan khera dabar najafgarh new delhi
South West
DELHI
110073
India |
| Phone |
7568730726 |
| Fax |
|
| Email |
dr_jaisinghyadav@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Institute block, Chaudhary brahm prakash ayurved charak sansthan, khera dabar, najafgarh, south west delhi, india 110073 |
|
|
Primary Sponsor
|
| Name |
Chaudhary Brahm prakash ayurved charak sansthan |
| Address |
Chaudhary brahm prakash ayurved charak sansthan,khera dabar najafgarh new delhi india 110073 |
| 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 Jai Singh Yadav |
Ch Brahm prakash ayurved charak sansthan |
OPD room no 20 of PG department of swasthavritta ch. brahm prakash ayurved charak sansthan, khera dabar, najafgarh new delhi-110073
South West
DELHI |
7568730726
dr_jaisinghyadav@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC CBPACS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L80-L99||Other disorders of the skin and subcutaneous tissue. Ayurveda Condition: YUVANAPIDAKA (MUKHADUSHIKA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | mukhprakshalana | (Procedure Reference: sushrut samhita, Procedure details: kashaya of amalaki is made according to sharangdhar samhita then applied over face twice a day)
(1) Medicine Name: amalaki, Reference: sushrut samhita, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 40(ml), Frequency: bd, Duration: 30 Days | | 2 | Comparator Arm | Procedure | - | mukhprakshalana | (Procedure Reference: sushrut samhita, Procedure details: kashaya of varuna is made according to sharandhar samhita and applied over face for twice a day.)
(1) Medicine Name: varuna, Reference: tripathi E. Vaidyaratnum, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 40(ml), Frequency: bd, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
patients having symptoms of acne vulgaris like multiple papular eruptions on face associated with pain, inflammation, discharge and discolouration and with associated symptoms like itching, blackheads whiteheads papules pustules redness around skin eruptions |
|
| ExclusionCriteria |
| Details |
1.history of hypersensitivity 2.patient having skin problems like scabies, eczema, fungal infections 3. patient on corticosteroids and antitubercular drugs 4. patient having acne due to acromegaly, androgen secreting tumours |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decreased grade of severity according to the CASS scale (comprehensive acne severity scale) |
0,15th,30th,45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in subjective parameters of acne vulgaris. |
0,15th,30th,45th day |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
01/03/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is randomized control trial to compare the effect of amalaki kashay mukhprakshalana and varun kashay mukhprakshalana in reducing the severity of yuvana pidika. In one group amalaki kashay is given for mukhprakshalana in two settings daily for 30 days with follow up on 15th, 30th, 45th day. in another group varun kashay mukhprashalana is given in two settings daily for 30 days with follow up on 15th, 30th, 45th day.The trial will be conducted in Ch. brahm prakash ayurved charak sansthan with outcome mukhprakshalana with amalaki kashay show better efficacy than varun kashay in reducing the severity of yuvana pidika in improving CASS score and other associated symptoms. |