| CTRI Number |
CTRI/2025/01/079182 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
16/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparative clinical trial of manjisthadikvath with dasang lepa and triphaladi kvath with arjunadi lepa in patients of yauvanpidika. |
|
Scientific Title of Study
|
A comparative clinical study of oral administration of Manjisthadi Kvatha with local application of Dasang Lepa and oral administration of Triphaladi Kvatha with local application of Arjunadi Lepa in the patients of Yauvanpidika(Acne Vulgaris) |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Goswami Astha Mukeshbharthi |
| Designation |
PG Scholar |
| Affiliation |
JS ayurveda mahavidhyalaya and PD patel ayurveda hospital |
| Address |
PG Department of kayachikitsa js ayurveda mahavidhyalaya and PD patel ayurveda hospital college road Nadiad,Kheda,Gujarat,India.
387001
Kheda
GUJARAT
387001
India |
| Phone |
7434837024 |
| Fax |
|
| Email |
asthagoswami164@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Dhaval Dholakiya |
| Designation |
professor |
| Affiliation |
P D PAtel Ayurvedic Hospital J S Ayurved Mahavidyalay |
| Address |
PG Department of kayachikitsa js ayurveda mahavidhyalaya college road nadiad
kheda
gujarat
387001
india
Kheda
GUJARAT
387001
India |
| Phone |
7016786089 |
| Fax |
|
| Email |
vddhavaldholakiya1910@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Dhaval Dholakiya |
| Designation |
professor |
| Affiliation |
P D PAtel Ayurvedic Hospital J S Ayurved Mahavidyalay |
| Address |
PG Department of kayachikitsa js ayurveda mahavidhyalaya college road nadiad
kheda
gujarat
387001
india
GUJARAT
387001
India |
| Phone |
7016786089 |
| Fax |
|
| Email |
vddhavaldholakiya1910@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sundar ayurveda pharmacy,JS ayurveda mahavidhyalaya and PD patel ayurveda hospital. |
|
|
Primary Sponsor
|
| Name |
JS ayurveda mahavidhyalaya and PD patel ayurveda hospital |
| Address |
JS ayurveda mahavidhyalaya and PD patel ayurveda hospital college road Nadiad-387001,Gujarat,India. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Goswami Astha Mukeshbharthi |
JS ayurveda mahavidhyalaya |
Department of kayachikitsa js ayurveda mahavidhyalaya PD patel ayurveda hospital college road nadiad.
kheda
gujarat
387001
india
Kheda
GUJARAT |
7434837024
asthagoswami164@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: MANJISTHADI KVATH, Reference: BHAISJYA RATNAVALI, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 8 Weeks, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: DASANG LEPA, Reference: SHARANGDHARA SAMHITA, Route: Topical, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 8 Weeks, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: TRIPHALADI KVATH, Reference: CARAK SAMHITA, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 8 Weeks, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: ARJUNADI LEPA, Reference: YOGARATNAKAR, Route: Topical, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 8 Weeks, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffuring from classical sign and symptoms of yauvanpidika at the site of face only. |
|
| ExclusionCriteria |
| Details |
Age below 18 years and above 30 years.
patients Having history of any systemic disease like D.M., HTN, Cardiac disease, Thyroidism, Renal disorder, Psychotic disorders, Liver disorders or any viral infection will be excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out the comparative effect of manjisthadi kvath with dasang lepa and triphaladi kvath with arjunadi lepa in the patients of yauvanpidika. |
2 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To improve the lustre and complexion of the skin. |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/01/2025 |
| Date of Study Completion (India) |
30/05/2026 |
| 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)
|
Acne is a visible disfiguring of the face, it produces a great deal of embarrassment, frustration, anger, and depression in patients of acne vulgaris .Acne is most common in adolescence and young adulthood, a time when patients are least capable of coping with additional stress ,Acne vulgaris is one of the most common skin disorders which involve face and this site where the person is more concern about the appearance and beauty. 20 patients are in each group( 2 groups ) who fulfill the inclusion criteria will be selected from OPD and give them oral administration of manjisthadi kvath( 40 ml twice a day on empty stomach) with local application of dasang lepa to 1st group, give oral administration of triphaladi kvath ( 40 ml twice a day on empty stomach) with local application of arjunadi lepa to 2nd group.patient will be treated for 8 weeks and check the comparative effect of both group medication. |