| CTRI Number |
CTRI/2025/08/093266 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
19/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Screening |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to Find Out if a Herbal Cream, With or Without Manjisthadi Agada, Helps Reduce Pimples Caused by Makeup or Cosmetic Products |
|
Scientific Title of Study
|
Evaluation of comparative efficacy of Polyherbal Cream with and without Manjisthadi Agad in the Management of Padminikantaka (Acne Cosmetica) |
| 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 Varnita Parashar |
| Designation |
PG SCHOLAR |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha |
| Address |
Department of Agadtantra and Vidhi Vaidyaka
Mahatma Gandhi Ayurved College Hospital and Research Centre
Salod Wardha Maharashtra INDIA PINCODE 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
8358044370 |
| Fax |
|
| Email |
parasharminnie@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varnita Parashar |
| Designation |
PG SCHOLAR |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha |
| Address |
Department of Agadtantra and Vidhi Vaidyaka
Mahatma Gandhi Ayurved College Hospital and Research Centre
Salod Wardha Maharashtra INDIA PINCODE 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
8358044370 |
| Fax |
|
| Email |
parasharminnie@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonali Chalakh |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha |
| Address |
Department of Agadtantra and Vidhi Vaidyaka
Mahatma Gandhi Ayurved College Hospital and Research Centre
Salod Wardha Maharashtra INDIA PINCODE 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9850366073 |
| Fax |
|
| Email |
sonali.chalakh@dmimsu.edu.in |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College and Research Centre DMIHER Salod Wardha Maharashtra India PINCODE 442001 |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Ayurved College Hospital and Research Centre DMIHER Salod Wardha |
| Address |
Department of Agadtantra and Vidhi Vaidyaka
Mahatma Gandhi Ayurved College Hospital and Research Centre DMIHER Salod Wardha Maharashtra India pincode 442001 |
| 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 |
| DR VARNITA PARASHAR |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha Maharashtra |
Department of Agadtantra and Vidhi Vaidyaka
Mahatma Gandhi Ayurved College Hospital and Research Centre
Salod Wardha Maharashtra INDIA PINCODE 442001
Wardha
MAHARASHTRA |
8358044370
PARASHARMINIE@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Ayurved College Hospital and Research Centre Institutional Ethics Committee Salod Wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: PADMINIKANTAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: manjisthadi Agad, Reference: bharat bhaishajya ratnakar, makaradimishraprakaran sholk 5684, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: madhu), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: polyherbal cream, Reference: sushrut kalpa sthana2/24, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: - | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: polyherbal cream, Reference: sushrut kalpa sthana 2/24, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
diagnosed with padminikantaka
sign consent before the study |
|
| ExclusionCriteria |
| Details |
below 18 and above 40 year
hormonal imbalance and irregular menstrual cycle
suffering form any systemic illnes
pregnant and lactating mother
PCOD, PCOS
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in acne severity |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduction in Post acne Scarring and improvement in skin texture |
1 month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
10/11/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 volunteers will be informed about the study protocol. Willing participants will be randomly selected as per the computer-generated table. the clinical research format will be prepared and validated. before the study approval is taken, IEC, MGACRC, Salod Wardha, and CTRI registration will be done. after selection, each participant will be tested individually and selected according to the selection criteria. they are divided into two groups. the trial is a randomized, open-label, standard control superior clinical trial. it will include a 1-month treatment period and follow-up. |