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CTRI Number  CTRI/2024/07/071671 [Registered on: 31/07/2024] Trial Registered Prospectively
Last Modified On: 05/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   To study the Efficacy of Manjishtadi Mukha Lepa in acne 
Scientific Title of Study   Single Arm Clinical Trial to Assess the Efficacy of Manjishtadi Mukha Lepa in Youvanapidika Along with Bacterial Colonization and Sebum Scoring 
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 Manu Krishnan 
Designation  PG scholar 
Affiliation  Amrita school of ayurveda 
Address  Amrita school of ayurveda Amrita Vishwa Vidyapeetham, Amritapuri, Clappana P.O. Kerala, India – 690525.

Kollam
KERALA
690525
India 
Phone  8943142193  
Fax    
Email  manukrishnan161@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr K Parameswaran Namboothiri 
Designation  Professor and H O D 
Affiliation  Amrita school of ayurveda 
Address  Amrita school of ayurveda Amrita Vishwa Vidyapeetham, Amritapuri, Clappana P.O. Kerala, India – 690525.

Kollam
KERALA
690525
India 
Phone  9496096694  
Fax    
Email  kpn@ay.amrita.edu  
 
Details of Contact Person
Public Query  
Name  Dr K Parameswaran Namboothiri 
Designation  Professor and H O D 
Affiliation  Amrita school of ayurveda 
Address  Amrita school of ayurveda Amrita Vishwa Vidyapeetham, Amritapuri, Clappana P.O. Kerala, India – 690525.

Kollam
KERALA
690525
India 
Phone  9496096694  
Fax    
Email  kpn@ay.amrita.edu  
 
Source of Monetary or Material Support  
Amrita School Of Ayurveda Amrita Vishwa Vidyapeetham, Amritapuri, Clappana P.O. Kerala, India – 690 525. 
 
Primary Sponsor  
Name  Dr Manu Krishnan 
Address  Amrita School of Ayurveda Amrita Vishwa Vidyapeetham, Amritapuri, Clappana P.O. Kerala, India – 690 525. 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manu Krishnan  Amrita School of Ayurveda  OPD number 2 Department of Panchakarma Amrita School of Ayurveda Amrita Vishwa Vidyapeetham, Amritapuri, Clappana P.O. Kerala, India – 690 525.
Kollam
KERALA 		 8943142193

manukrishnan161@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC Amrita School Of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L709||Acne, unspecified. Ayurveda Condition: YUVANAPIDAKA (MUKHADUSHIKA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-lepa, लेप (Procedure Reference: shaarangadhara samhita 11/9, Procedure details: manjishtadi mukhalepana once daily)
(1) Medicine Name: manjishtadi lepa, Reference: chakradutta chapter 55 sloka 60-62, Route: Topical, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: od, Duration: 14 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1.Patients between the age group of 18-30 years,
irrespective of gender
2.Patient assessed with GAGS scoring mild to moderate
 
 
ExclusionCriteria 
Details  1.Acne caused due to an underlying systemic disorders, drug induced acne and seborrheic dermatitis
2.Acne cosemtica
3.Rosacea
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of manjishtadi lepa in youvanapidika using GLOBAL ACNE GRADING SCALE  14th day 
 
Secondary Outcome  
Outcome  TimePoints 
To identify the alteration of Cutibacterium acne colonization using bacterial culture method and sebum production using DERMALAB COMBO in youvanapidika after administration of manjistadi lepa
 		 0th day,7th day,14th day 
 
Target Sample Size   Total Sample Size="31"
Sample Size from India="31" 
Final Enrollment numbers achieved (Total)= "31"
Final Enrollment numbers achieved (India)="31" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   20/08/2024 
Date of Study Completion (India) Date Missing 
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)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
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  

Acne is a chronic inflammatory disease of the pilosebaceous unit resulting from androgen-induced increased sebum production, altered keratinisation, inflammation, and bacterial colonisation of hair follicles on the face, neck, chest, and back by Propionibacterium acne. It is estimated to affect 9·4% of the global population, making it the eighth most prevalent disease worldwide.

In Ayurveda, Acne is corelated to Yauvanapidika which is caused by Kapha, Vata, and Rakta vitiation. Sharangadhara has mentioned Vaktre Snigdhata (unctuousness on face) and Pidika (boil) on face as mala. Manjishtadi thaila is explained in chakradutta in kshudra roga and explained as neelikapidakavyanga abhyangat eva nashayeth.

On the skin surface, the microbial community is mostly constituted by bacteria belonging to the three main genera of Corynebacteria, Propionibacterium and Staphylococci. The colonization of the pilosebaceous follicle by P. Acnes is considered as one of the central factors driving acne by taking part in the inflammatory response of the skin. Presently various treatment modalities are adopted for acne which includes anti-inflammatory, antibiotics, and comedolytic agents. However, they are reported to be expensive and with many adverse effects. Lepa is an effective treatment in acne management. This treatment is simple, effective, safe and convenient to patients in the busy schedule of modern era.

AIMS –

• To assess the efficacy of manjishtadi mukha lepa in the management of youvanapidika along with alterations in bacterial colonization and sebum production.

OBJECTIVES-

• To assess the efficacy of manjishtadi mukha lepa in youvana pidika

• To identify the alteration of Cutibcaterium acne colonization and sebum production in youvanapidika after administration of lepa

METHODOLOGY This is a single group pre and post-test clinical study to do the clinical evaluation of a serum. Prepared by convertion of lepa with Vata, Lodra and Manjishta. The sample size is 35 with study duration of 18 months,treatment duration of 30 days. Patients, who are fulfilling the inclusion criteria will be selected from the OPD of Amrita School of Ayurveda. They will be provided of manjishtadi lepa for external application on face for 14 days.

 
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