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CTRI Number  CTRI/2024/10/075152 [Registered on: 11/10/2024] Trial Registered Prospectively
Last Modified On: 30/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To evaluate the proper emetic symptoms of Madanaphala varti against conventionally used emetic drug in Acne 
Scientific Title of Study   A Randomised Controlled Trial to evaluate the Samyak Vamana Lakshana of Madanaphala varti against Conventional Vamnoushadha in Mukhadushika(Acne) 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrSaranya C V 
Designation  PG Scholar 
Affiliation  Vaidyaratnam PS Varier Ayurveda College  
Address  Department of Panchakarma Vaidyaratnam PS Varier Ayurveda College Kottakkal Edarikode PO Malappuram Kerala 676501 India

Malappuram
KERALA
676501
India 
Phone  9947923431  
Fax    
Email  saranyacwarrier@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr A K Manojkumar 
Designation  Professor and HOD 
Affiliation  Vaidyaratnam PS Varier Ayurveda College  
Address  Department of Panchakarma Vaidyaratnam PS Varier Ayurveda College Kottakkal Edarikode PO Malappuram Kerala 676501 India

Malappuram
KERALA
676501
India 
Phone  9447184275  
Fax    
Email  drakmanoj@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Binitha A 
Designation  Professor 
Affiliation  Vaidyaratnam PS Varier Ayurveda College  
Address  Department of Panchakarma Vaidyaratnam PS Varier Ayurveda College Kottakkal Edarikode PO Malappuram Kerala 676501 India

Malappuram
KERALA
676501
India 
Phone  9895201635  
Fax    
Email  drbinithaunni@gmail.com  
 
Source of Monetary or Material Support  
Vaidyaratnam PS Varier Ayurveda College 
 
Primary Sponsor  
Name  Vaidyaratnam PS Varier Ayurveda College  
Address  Department of Panchakarma Vaidyaratnam PS Varier Ayurveda College Kottakkal Malappuram Kerala 676501 India 
Type of Sponsor  Other [Aided college] 
 
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 Saranya C V  Vaidyaratnam PS Varier Ayurveda College Kottakkal  OPD Department of Panchakarma Room number A112 Vaidyaratnam PS Varier Ayurveda College Kottakkal Edarikode PO Malappuram Kerala 676501 India
Malappuram
KERALA 		 9947923431

saranyacwarrier@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee(IEC)  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: PIDAKA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-vamana-karma/ pracCardanam, वमन-कर्म/ प्रच्छर्दनम् (Procedure Reference: Ashtanga hridayam (Vagbhada),soothrasthana,18/12;p.227, Procedure details: Sadyasneha with plain cow s ghee Utklesha on previous day of vamanakarma Abhyanga with tila taila and ushma sweda on the day of vamanakarma Vamana dravya will be given After that aakandapana with yashti phanta Time of procedure 5:30am )
(1) Medicine Name: Madanapippali choorna,vacha,yashti choorna,saindhava,honey,yashti phanta, Reference: Aneesh E G .Validation of Standardoperative procedure of Vamanakarma in psoriasis- A randomised clinical trial(PG Dissertation),Dept of panchakarma,VPSV Ayurveda college,Kottakkal:Kerala University Of Health Science;2016, Route: Oral, Dosage Form: Kalka/ Paste, Dose: 42(g), Frequency: od, Duration: 1 Days
2Intervention ArmProcedure-vamana-karma/ pracCardanam, वमन-कर्म/ प्रच्छर्दनम् (Procedure Reference: Ashtanga hridayam (Vagbhada),soothrasthana,18/12;p.227, Procedure details: Sadyasneha with plain cow s ghee Utklesha on previous day of vamanakarma Abhyanga with tila taila and ushma sweda on the day of vamanakarma Vamana dravya will be given After that aakandapana with yashti phanta Time of procedure-5:30am )
(1) Medicine Name: Madanaphala varti,Yashti phanta, Reference: Jadavji Trikamji.Caraka Samhita.Reprint ed.Kalpāsthana Ch.1/21 Choukhambha Orientalia,Varanasi;2022.655p, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 4(NA), Frequency: od, Duration: 1 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Participants fullfilling the diagnostic criteria
Participants willing to give informed consent
Participants fit for vamanakarma 
 
ExclusionCriteria 
Details  Pregnant and lactating women
Participants with uncontrolled Hypertension
Diagnosed cases of Haemorrhagic disorders, Esophageal varices, Liver cirrhosis, Active peptic ulcer
Tortuous vein in the neck and forehead
Known cases of Psoriasis, Eczema, Fungal infections, Vitiligo, Urticaria, Asthma, Chloracne Participant with known case of Hypothyroidism, PCOD
Participants with Cosmetic allergy 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Proper symptoms of emetic therapy (Number of bouts,Quantity of emetic content,End point,symptoms)  on the day of vamanan karma 
 
Secondary Outcome  
Outcome  TimePoints 
GAGS(Global Acne Grading System)
DLQI(Dermatology Life Quality Index)
Skin Microbiome(16s rRNA gene sequencing) 		 on 0th day 12th day of vamana 
 
Target Sample Size   Total Sample Size="26"
Sample Size from India="26" 
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   N/A 
Date of First Enrollment (India)   30/10/2024 
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="1"
Months="6"
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   A randomized controlled trial involving 26 participants with MukhadÅ«shika. The participants will be randomized in to two groups following computer generated random numbers where control group will receive conventional Vamanoushadha for Vamanakarma and trial group will receive Madanaphala varti for Vamanakarma. The Samyak vamana lakshana will be assessed in both groups in terms of Vaigiki, Māniki, Ä€ntiki and Laingiki (on the day of vamanakarma). Disease activity will be monitered by GAGS and DLQI questionniere, The diversity in skin microbiome will be analysed by 16S rRNA sequencing.(before and after the treatment) 
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