| CTRI Number |
CTRI/2018/02/011656 [Registered on: 01/02/2018] Trial Registered Prospectively |
| Last Modified On: |
31/01/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment of fresh wound with indravaruni ointment |
|
Scientific Title of Study
|
A CLINICAL STUDY ON MANAGEMENT OF SHUDDHA VRANA (FRESH OPEN WOUND )WITH INDRAVARUNI FRUIT OINTMENT |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amir pathan |
| Designation |
Pg scholar |
| Affiliation |
Parul institute of ayurveda |
| Address |
Opd no 116 , parul ayurvedic hospital , post-Limda, tq. Waghodia , vadodara, india
Parul institute of ayurveda , parul university ,po.limda ,tq.waghodia , vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9423847252 |
| Fax |
|
| Email |
dr.amirkhan27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrVivekanand kullolli |
| Designation |
Professor |
| Affiliation |
Parul institute of ayurveda |
| Address |
Opd no 116 , parul ayurvedic hospital , post-Limda, tq. Waghodia , vadodara, india
Opd no 116 , parul ayurvedic hospital , post-Limda, tq. Waghodia , vadodara, india
Vadodara
GUJARAT
391760
India |
| Phone |
9945079276 |
| Fax |
|
| Email |
Vivekkullolli@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amir pathan |
| Designation |
Pg scholar |
| Affiliation |
Parul institute of ayurveda |
| Address |
Opd no 116 , parul ayurvedic hospital , post-Limda, tq. Waghodia , vadodara, india
Parul institute of ayurveda , parul university ,po.limda ,tq.waghodia , vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9423847252 |
| Fax |
|
| Email |
dr.amirkhan27@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul institute of ayurveda and hospital , limda , vadodara , gujarat |
|
|
Primary Sponsor
|
| Name |
Department of Shalya tantra |
| Address |
Parul institute of Ayurveda, Parul university,Limda, Vadodara. |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Amir Pathan |
Parul institute of Ayurveda And Hospital |
OPD NO 116 Parul Ayurved Hospital,Parul university post-Limda Tq-Waghodia, Dist-Vadodara
Vadodara
GUJARAT |
9423847252
dr.amirkhan27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patient with fresh Wound of lenth upto12cm and depth 0.5 cm , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Betadine Ointment |
Patients Treating with Betadine Ointment Topical Application As per Requirements of Wound size Ones daily till complete Epithelisation of Wound |
| Intervention |
Indravaruni Fruit Ointment |
Patient Treating with Indravaruni Fruit Ointment Topical Application As per Requirement of Wound size Ones daily Till Complete Epithelisation Of Wound |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1- Patient having fresh wound and those who having shuddha varna lakshanas mentioned as per Ayurvedic text will selected
2-Wound size :- length upto 12 cm and depth 0.5 cm
|
|
| ExclusionCriteria |
| Details |
1-Patient having infected wound
2- those who are having visceral,bony,spinal injury
3- Patient with electrical,chemical,burn injuries
4-Patient sufffering from any systemic disease like DM and other infectious disease will be excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Healing the wound |
With in two weeks or 10-15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain reduce, No secondary infections. |
In 1-2 weeks |
|
|
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
14/02/2018 |
| 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="0"
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
|
1- Hypothesis :- Indravaruni (Citrullus colocynthis) does possess wound healing property .
|