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CTRI Number  CTRI/2020/02/023656 [Registered on: 28/02/2020] Trial Registered Prospectively
Last Modified On: 27/02/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   “A Clinical study to study the effect of an ointment made of haridra in wounds . 
Scientific Title of Study   “A Clinical study to evaluate the efficacy of haridra malahara in the management of sadyovrana. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vishnu R 
Designation  MD Scholar 
Affiliation  Rajiv Gandhi University of Health Sciences Bangalore 
Address  Alvas Ayurveda Medical College And Hospital,Vidyagiri,Moodbidri,Dakshina Kannada,Karnataka.

Dakshina Kannada
KARNATAKA
574227
India 
Phone  7259596808  
Fax    
Email  kandalilvishnu@ymail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mahabaleshwar 
Designation  Associate Professor and Guide 
Affiliation  Rajiv Gandhi University of Health Sciences Bangalore 
Address  Alvas Ayurveda Medical College And Hospital,Vidyagiri,Moodbidri,Dakshina Kannada,Karnataka.

Dakshina Kannada
KARNATAKA
574227
India 
Phone  9886620260  
Fax  08258-236731  
Email  drmahabalesh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mahabaleshwar 
Designation  Associate Professor and Guide 
Affiliation  Rajiv Gandhi University of Health Sciences Bangalore 
Address  Alvas Ayurveda Medical College And Hospital,Vidyagiri,Moodbidri,Dakshina Kannada,Karnataka.

Dakshina Kannada
KARNATAKA
574227
India 
Phone  9886620260  
Fax    
Email  drmahabalesh@gmail.com  
 
Source of Monetary or Material Support  
Alvas Ayurveda Medical College and Hospital  
 
Primary Sponsor  
Name  Dr Vishnu R 
Address  Room no 103 Godavari apts ,Nehru Nagar ,Ramanthapur ,Hyderabad. 
Type of Sponsor  Other [Self financed] 
 
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 Vishnu R  Alvas Ayurveda Medical College And Hospital.  Room no 3 Minor O T,Department of Shalya Tantra, Alvas Ayurveda Medical College And Hospital,Vidyagiri Moodbidri,Dakshina Kannada,Karnataka.
Dakshina Kannada
KARNATAKA 		 7259596808

kandalilvishnu@ymail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Clinical Ethical Committee Alvas Ayurveda Medical College   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: T07||Unspecified multiple injuries,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Haridra Malahara Dressing  Distilled water Cleaning and dressing with Haridra Malahara will done every day till the wound heals or upto 21 days Periodical observation will be done on – 7th , 14th, 21st and 28thday. 
Intervention  Povidone Iodine Dressing  Distilled water Cleaning and dressing with Povidone Iodine will done every day till the wound heals or upto 21 days Periodical observation will be done on – 7th , 14th, 21st and 28thday. 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Sadyovrana of following dimensions:
Maximum length:5cm.
Maximum width:5cm.
Maximum Depth:5 mm.
- Patients of either sex.
- Wounds within 7 days.
- Kshataja Vrana (Laceration).
- Ghrishta Vrana (Abrasions).
- Chinna Vrana (Excised wound).

 
 
ExclusionCriteria 
Details  -Patients with systemic disorders like Type II DM, HTN, Bleeding disorders and leprosy.
-Dushta vrana.
-The patients having Sadyovrana with other complications like fractures, Marmaghata.
- Pregnant patients
- Medico-legal cases.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Haridra Malahara has better wound healing property,anti inflamatory property.  Periodical observation will be done on – 7th , 14th, 21st and 28thday.
 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Haridra Malahara.
 		 Follow up: The patients of both groups will be advised to come for follow up on 35th and 42nd day.
 
 
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 2/ Phase 3 
Date of First Enrollment (India)   01/03/2020 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   https://www.ncbi.nlm.nih.gov/pubmed/ 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This study is a randomized, Single blind, parallel group,  trial To evaluate the Efficacy of Haridra Malahara for 28 days in 30 patients with Sadyovrana,that will be conducted in one center in India. The primary outcome measures will be the wound healling Property . 
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