| CTRI Number |
CTRI/2024/07/069888 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
10/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical study of application shalmali kantak extract in the form of arka and gel form in pimples. |
|
Scientific Title of Study
|
A Pharmaceutico - Analytical and clinical study of Shalmalikantaka Arka along with its modified form as gel in Mukhadushika |
| Trial Acronym |
nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Indira V |
| Designation |
PhD scholar Assistant professor |
| Affiliation |
JS Ayurvedamahavidylay |
| Address |
OPD No 135 Dept of Shalakya tantra JS Ayurvedamahavidyalay and PD Patel Ayurveda hospital College road Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
8050158292 |
| Fax |
|
| Email |
indiravenu50@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ganga Hadimani |
| Designation |
Professor |
| Affiliation |
JS Ayurvedamahavidylay |
| Address |
OPD No 135 Dept of Shalakya tantra JS Ayurvedamahavidyalay and PD Patel Ayurveda hospital College road Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
8780067570 |
| Fax |
|
| Email |
gangupatil2001@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ganga Hadimani |
| Designation |
Professor |
| Affiliation |
JS Ayurvedamahavidylay |
| Address |
OPD No 135 Dept of Shalakya tantra JS Ayurvedamahavidyalay and PD Patel Ayurveda hospital College road Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
8780067570 |
| Fax |
|
| Email |
gangupatil2001@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Rasashastra evam Baishajya kalpana JS Ayurveda mahavidylay & PD Patel Ayurveda hospital College road Nadiad Kheda District Gujarat India Pin code 387001 |
|
|
Primary Sponsor
|
| Name |
Dr Indira V |
| Address |
JS Ayurvedamahavidylay & PD Patel Ayurveda hospital College road Nadiad Kheda District Gujarat India pin code 387001 |
| 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 |
| Dr Indira V |
JS Ayurveda mahavidyala & PD Patel Ayurveda hospital college road Nadiad Gujarat |
JS Ayurveda mahavidyala & PD Patel Ayurveda hospital college road Nadiad Gujarat
Kheda
GUJARAT |
8050158292
indiravenu50@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maganbhai Adenwala Mahagujarat University Institutional ethics committee for human research |
Approved |
|
|
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 | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: shalmalikantaka Arka, Reference: Arkaprakasha 7/5, Route: Topical, Dosage Form: Arka, Dose: 10(drops), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: NA | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: shalmalikantaka gel, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: NA |
|
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having symptoms of Mukhadushika as mentioned in Classics are included.
2. Patients between the age group of 13 years to 35 years, irrespective of religion, sex, socio-economic status, occupation are included for the study.
|
|
| ExclusionCriteria |
| Details |
1. Patients having Pidaka as of other Kshudra Roga and Kushta are excluded.
2. Patients associated with any Systemic and metabolic disorders are excluded.
3. Patients of the age group less than 13 years and more than 35 years are excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.it helps to cure acne.
2. helps to clear acne marks. |
once in a week, 4 times after study period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| GAGS Score |
once in a week, 4 times after study period. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/07/2024 |
| Date of Study Completion (India) |
20/09/2025 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Study type : Interventional Interventional model: two groups assignment Purpose : Treatment Allocation : Randomized Timing : prospective Sample : minimum 40 Outcome : efficacy of treatment protocol Duration : 30 days · GROUPING: Minimum 40 patients. All the patients will be divided into two groups by randomized clinical study. Group A: Minimum 20 patients. Drug (A): shalmalikantaka arka Dose : as required for the affected area Duration : 30 days Form : Arka Group B: Minimum 20 patients. Drug (B): shalmalikantaka arka Gel Dose : as required for the affected area Duration : 30 days Form : gel - 20 pts will be randomly selected and after fulfilling the inclusion criteria as mentioned in the clinical proforma will be subjected for the application of shalamalikantaka arka for a period of 30 days.
- Mode of application of shalamalikantaka arka: Take 6-8 drops of arka and applied on effected area of face and give a gentle massage, allow it dry for 30 minutes, then face should be washed with Luke warm water.
- Similarly,20 pts will be randomly selected who will fulfill inclusion criteria of Mukhadushika and advised to apply shalmalikantaka arka gel, twice a day for 30days.
- Mode of application of gel: take sufficient quantity of gel and apply over the affected area of face and give a gentle massage, allow it to absorb for 30 minutes, then face should be washed with normal water.
- Study will be carried out on the patients fulfilling the inclusion criteria of Mukhadhooshika. The result of treatment of both groups will be statistically analyzed.
|