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CTRI Number  CTRI/2022/07/044012 [Registered on: 14/07/2022] Trial Registered Prospectively
Last Modified On: 29/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Clinical study on Anti-acne face pack in pimples 
Scientific Title of Study   Evaluation of Efficacy and Safety of Anti-acne Face Pack in participants suffering from Acne Vulgaris- An open label, non-comparative, interventional, prospective, clinical study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
ACNEFACEPCK/NAMSKARAYU/2022/1, Version 2.0, 07th June 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pawar Sumol Anand 
Designation  Assistant Professor  
Affiliation  Late. Babruwan Vitthalrao Kale Ayurved Medical college and Hospital, Latur 
Address  OPD No. 10, Ground floor, Department of Panchakarma, Late. Babruwan Vitthalrao Kale Ayurved Medical college and Hospital, Latur, Behind Bus Stand, Gandhi Maidan, Latur

Latur
MAHARASHTRA
413512
India 
Phone  8793727304  
Fax    
Email  drsumolapawar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sanjay Tamoli 
Designation  Director 
Affiliation  Target Institute of Medical Education and Research Pvt. Ltd. 
Address  Target Institute of Medical Education and Research Pvt. Ltd. A Wing 402- A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad west, Mumbai

Mumbai (Suburban)
MAHARASHTRA
400064
India 
Phone  9322522252  
Fax    
Email  targetinstitute@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sanjay Tamoli 
Designation  Director 
Affiliation  Target Institute of Medical Education and Research Pvt. Ltd. 
Address  Target Institute of Medical Education and Research Pvt. Ltd. A Wing 402- A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad west, Mumbai


MAHARASHTRA
400064
India 
Phone  9322522252  
Fax    
Email  targetinstitute@yahoo.com  
 
Source of Monetary or Material Support  
Late. Babruwan Vitthalrao Kale Ayurved medical college and hospital, Latur 
 
Primary Sponsor  
Name  Namaskar Ayurved Private Limited 
Address  Unit - 4, Ground Floor,Peninsula Chambers Peninsula Corp Park G K Marg Lower Parel Mumbai-400013  
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Pawar Sumol Anand  Late. Babruwan Vitthalrao Kale Ayurved medical college and hospital, Latur  OPD No. 10, Ground floor, Department of Panchakarma, Late. Babruwan Vitthalrao Kale Ayurved medical college and hospital, Latur, Behind Bus Stand, Gandhi Maidan, Latur – 413512
Latur
MAHARASHTRA 
8793727304

drsumolapawar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Late. Babruwan Vitthalrao Kale Ayurved medical college and hospital, Latur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L700||Acne vulgaris. Ayurveda Condition: YUVANAPIDAKA (MUKHADUSHIKA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Anti-acne face pack, Reference: NA, Route: Topical, Dosage Form: Lepa Churna, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Samudga, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Subjects will be asked to apply Anti-acne Face Pack on face once daily for a period of 30 days. Subjects will be advised to apply an even layer of Face Pack over face. Subjects will be advised to retain Anti-acne Face Pack on face for at least 10-15 mins then wash face with warm water.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1. Subjects suffering from acne vulgaris [mild and moderate as per Global Acne Grading System (GAGS)] as diagnosed by physician or dermatologist
2. Subjects willing to follow study instructions given by the investigator
 
 
ExclusionCriteria 
Details  1. Subjects with known pre-existing systemic disease necessitating long-term medications.
2. Subjects with known current endocrinal disorders.
3. Subjects taking treatment for menstrual disorders
4. Subjects having systemic treatment for acne vulgaris.
5. Subjects on any other investigational products within 1 month prior to randomization;
6. Subjects with known current tuberculosis, HIV, ischemic heart disease, cancer, kidney failure.
7. Pregnant and lactating women
8. Known hypersensitivity to any of the ingredients of Anti-acne Face Pack
9. Other conditions, which in the opinion of the investigators, make patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in total number of inflammatory acne lesions on face   Screening / Baseline visit (Day 0), visit 1 (Day 15), visit 2 (Day 30), visit 3 (Day 45) 
 
Secondary Outcome  
Outcome  TimePoints 
1. Changes in total numbers of non-inflammatory acne lesions
2. Changes in total lesion count (inflammatory and non-inflammatory)
3. Difference in number of comedones (blackheads and whiteheads)
4. Changes in severity of acne vulgaris
5. Changes in signs and symptoms of acne vulgaris
6. Changes in acne scarring
7. Changes in skin lightening effect
8. Changes in post acne dark spots
9. Global assessment for overall change by participants and by physician
10. Assessment of post treatment tolerability of study drug by participants and physician.
11. Assessment of adverse events/adverse drug reactions including vitals
 
Screening / Baseline visit (Day 0), visit 1 (Day 15), visit 2 (Day 30), visit 3 (Day 45) 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   18/07/2022 
Date of Study Completion (India) 21/09/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

It is an open label, non-comparative, interventional, prospective, clinical study to evaluate efficacy and safety of Anti-acne Face Pack in participants suffering from Acne Vulgaris. Subjects will be asked to apply Anti-acne Face Pack on face once daily for a period of 30 days. Subjects will be advised to apply an even layer of Face Pack over face. Subjects will be advised to retain Anti-acne Face Pack on face for at least 10-15 mins then wash face with warm water. Subjects will be asked to stop trial medication after completion of 30 days and ask to come for follow up on day 45 to check recurrence of Acne vulgaris. The primary objective of the study will be to assess changes in total number of inflammatory acne lesions on face. The secondary objectives of the study will be to assess total numbers of non-inflammatory acne lesions, total lesion count (inflammatory and non-inflammatory), difference in number of comedones (blackheads and whiteheads), severity of acne vulgaris, signs and symptoms of acne vulgaris, acne scarring, skin lightening effect, post acne dark spots, global assessment for overall change by participants and by physician, post treatment tolerability of study drug by participants and physician and adverse events/adverse drug reactions including vitals on screening / baseline visit (Day 0), visit 1 (Day 15), visit 2 (Day 30), visit 3 (Day 45)

Results and Conclusion:

Namaskar Ayurved Anti-acne face pack was significantly effective in reducing inflammatory, non-inflammatory acne lesions, comedones (blackheads and whiteheads), symptoms of acne vulgaris including pain, edema, erythema, burning, scaling and itching, post acne dark spot, acne scarring and severity of acne vulgaris. No recurrence in any of the signs and symptoms of acne vulgaris was observed after stoppage of treatment for 15 days. Namaskar Ayurved Anti-acne face pack was safe in subjects suffering from acne vulgaris. 

 
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