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CTRI Number  CTRI/2024/08/072223 [Registered on: 09/08/2024] Trial Registered Prospectively
Last Modified On: 07/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to test the efficacy of Lodhradi Facepack in Acne vulgaris(Mukhadushika) 
Scientific Title of Study   Efficacy of Lodhradi Facepack in Acne Vulgaris(Mukhadushika) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sumy Basheer 
Designation  MD scholar 
Affiliation  Government Ayurveda college, Thiruvananthapuram 
Address  Department of Dravyaguna Vigyana Govt. Ayurveda College Thiruvananthapuram

Thiruvananthapuram
KERALA
695001
India 
Phone  9496374759  
Fax    
Email  sumyshamin1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Indulekha V C  
Designation  Associate Professor  
Affiliation  Government Ayurveda college, Thiruvananthapuram 
Address  Department of Dravyaguna Vigyana Government Ayurveda college, Thiruvananthapuram

Thiruvananthapuram
KERALA
695001
India 
Phone  9446553068  
Fax    
Email  drindulekha@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Indulekha V C  
Designation  Associate Professor  
Affiliation  Government Ayurveda college, Thiruvananthapuram 
Address  Department of Dravyaguna Vigyana Government Ayurveda college, Thiruvananthapuram


KERALA
695001
India 
Phone  9446553068  
Fax    
Email  drindulekha@gmail.com  
 
Source of Monetary or Material Support  
Govt Ayurveda College Pulimood junction Thiruvananthapuram 695001 
 
Primary Sponsor  
Name  Dr Sumy Basheer 
Address  Sumy Basheer Dept of Dravyaguna Vigyana Govt Ayurveda College Thiruvananthapuram Kerala 695001 
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 Sumy Basheer  Govt Ayurveda College Thiruvananthapuram  OP No 1 Department of Dravyaguna Vigyana Govt Ayurveda College Hospital Ppulimood junction Thiruvananthapuram
Thiruvananthapuram
KERALA 		 9496374759

sumyshamin1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee,Govt Ayurveda college   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: Lodhradi facepack paste, Reference: NA, Route: Topical, Dosage Form: Kalka/ Paste, Dose: 5(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmDrugOther than Classical(1) Medicine Name: Lodhradi facepack, Reference: NA, Route: Topical, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  Participants with Global Acne Grading Score (GAGS) between 19-30 of age group 18-35yrs
 
 
ExclusionCriteria 
Details  Pregnant or Lactating women
Patients under other medications for Acne vulgaris

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in GAGS Score
 		 0th day

56th day 
 
Secondary Outcome  
Outcome  TimePoints 
for standardisation of study drug physical parameters like ash value ,extractive value,TLC  Before starting study 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 
Date of First Enrollment (India)   26/08/2024 
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="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  on personal contact via google drive

  6. For how long will this data be available start date provided 26-08-2024 and end date provided 09-04-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Acne vulgaris is a chronic, inflammatory skin disease of the pilosebaceous unit, with open or closed comedones, papules, pustules, or nodules on the face or trunk, result in pain, erythema, hyperpigmentation, or scars. 9.4% of the global population has acne and 85% of them are teenagers. Treatments as per American Dermatological association guidelines include topical therapies, systemic antibiotics, hormonal agents, oral isotretinoin, physical modalities, complementary and alternative medicine, and dietary and environmental interventions. Though topical antibiotic therapies are the mainstay of grade II acne; adverse effects like irritant dermatitis, bacterial resistance are big concerns. Herbal medicines are becoming a promising strategy in cosmetics and skin care products and researches showed effectiveness of herbal and Ayurveda formulations in moderate acne vulgaris (Mukhadushika) with fewer adverse events. Mukhadushika charecterised by   Salmali-kantakaakara pidaka [lesions resembling the prickles of  silk cotton tree] , yoonam vakre [occurs in the  face  of young people]  sarujam (associated with pain),Ghana:[thick and dense lesion],medogarbha: [presence of fatty pultaceous material inside the lesion] The drugs having varnya(enhancing complexion), kushtaghna(curing skin diseases), kandoogna(antipruritic) and krimigna(Antihelminthic) actions are utilized in Ayurveda treatment. Lodhradi Facepack (LF) is a novel medicine formulated with bark of Lodhra (Symplocos cochinchinensis.Lour.), root of Manjishta (Rubia cordifolia L.), rhizhome of  Yashtimadhu (Glycyrrhiza glabra L.) and Multani-mitti (Fullers earth); which are having Mukhadushikahara, Varnya and Kandugna properties. Also unlike  antibiotics ,herbal medications have no side effects  like irritant dermatitis, bacterial resistance  etc  . Present medication  if proved to be effective can be used independently in moderate Acne vulgaris and adjuvant  in severe acne along with other medications.

 

 
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