CTRI Number |
CTRI/2018/07/014875 [Registered on: 16/07/2018] Trial Registered Prospectively |
Last Modified On: |
11/07/2018 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Wound Healing Property of Ayurvedic Ointment |
Scientific Title of Study
|
Vrunaropana Effect Of Durvanisha Ointment In Shuddhavruna, A Randomised Controlled
Clinical Trial
|
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Shivanarayan Prasad Gupta |
Designation |
PG Scholar |
Affiliation |
KAHERs Shri B M K Ayurveda Mahavidyalaya |
Address |
KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur, Belagavi Karnataka 590003
Belgaum KARNATAKA 590003 India |
Phone |
8051432396 |
Fax |
|
Email |
drshivanarayangupta@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Shivanarayan Prasad Gupta |
Designation |
PG Scholar |
Affiliation |
KAHERs Shri B M K Ayurveda Mahavidyalaya |
Address |
KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur, Belagavi Karnataka 590003
KARNATAKA 590003 India |
Phone |
8051432396 |
Fax |
|
Email |
drshivanarayangupta@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Santosh Y M |
Designation |
Reader Dept of Shalya Tantra |
Affiliation |
KAHERs Shri B M K Ayurveda Mahavidyalaya |
Address |
KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur, Belagavi Karnataka 590003
Belgaum KARNATAKA 590003 India |
Phone |
8660800928 |
Fax |
|
Email |
drmysantosh@gmail.com |
|
Source of Monetary or Material Support
|
KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka 590003 |
|
Primary Sponsor
|
Name |
KAHERs Shri B M K Ayurveda Mahavidyalaya |
Address |
KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
Name |
Address |
KAHERs Shri B M K Ayurveda Mahavidyalaya |
KAHERs Shri B M K Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka |
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Shivanarayan Prasad Gupta |
KLE Ayurveda Hospital |
Dept of Shalya Tantra - OPD No 08 & IPD patients of KLE Ayurveda Hospital Shahapur Belagavi 590003 Belgaum KARNATAKA |
8051432396
drshivanarayangupta@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee KAHER s Shri B M Kankanwadi Ayurveda Mahavidyalaya and KLE Ayurveda Hospital Shahapur Belagavi |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Either sex between 20-70 years of age group.
Patients with the Laxanas of Shuddha Vruna
, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Durvanisha ointment |
Drugs required for the preparation of Durvanisha ointment will be collected from KLEs GMP Certified Ayurved Pharmacy, Khasbag, Belagavi and natural habitat.Durvanisha ointment will be preparaed in the Dept of Rasashastra & Bhaishajyakalpana adopting proper SOP under the supervision of experts.Control drug will be procured from GMP certified KLE’s Ayurveda Pharmacy, Khasbag. The prepared drug will be applied externally for 7 days |
Comparator Agent |
Jatyadi tail |
Its a ayurveda medicinal preparation in the Oil base which will be applied externally for 7 Days |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
Either sex between 20-70 years of age group.
Patients with the Laxanas of ShudhaVrana
|
|
ExclusionCriteria |
Details |
Patients suffering from ashuddha vruna (wounds associated with systemic diseases like diabetes mellitus, tuberculosis, malignant wounds, HbsAg, HIV I & II). |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
The Durvanisha ointment is helpful in treating shuddha Vruna |
0th, 7th, 15th |
|
Secondary Outcome
|
Outcome |
TimePoints |
Not Applicable |
Not Applicable |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
01/10/2018 |
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
|
None Yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
The Vruna is one which causes gatravichurnana and does the vivarnata of the shareera which is described as a break in the continuity of tissue, from violence or trauma and is regarded as healed if there is a restoration of the wounded or inflamed tissue to normal condition. Wound healing is an important biological process involving tissue repair and regeneration and various stages. Worldwide prevalence of wounds is 1%, estimated that 1.5 million cases of traumatic wounds found every year, whereas an Indian perspective of hospital based study shows diabetes (23%), venous disease (11%) and trauma (13%), and were the important causes of extremity wounds. We get the reference of Vruna description in detail in regards to definition, classification and management in the classics. Its effective management for a surgeon is the basic skill required on which the outcome of surgery revolves. There was, however, a hundred percent (100 %) healing in the animals treated with ointments containing 100mg/g of Haridra(Curcuma longa), and Durva (Cynodon dactylon) in cationic emulsifying agent after treatment, as the wound sizes reduced to zero. Many herbal preparations have been tried in the past research studies as vruna ropana but they had their own drawbacks like they have time consuming. So keeping this as main goal the present study is under taken to evaluate the efficacy of Durvanisha ointment in clinical trial. |