| CTRI Number |
CTRI/2024/06/068458 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
05/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of karpoor ghrit as ropan in management of sadhyovrana |
|
Scientific Title of Study
|
Randomized open controlled clinical study to asses the effect of karpoor ghrit as ropan in management of sadhyovrana |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chinmay Bajarang Bhosale |
| Designation |
PG scholar |
| Affiliation |
Yashwant Ayurvedic college post graduate training and research centre Kodoli |
| Address |
OPD NO.4 Shalya Tantra Department second floor Yashwant Ayurvedic college post graduate training and research centre Kodoli tal pahala dist kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8483836251 |
| Fax |
|
| Email |
bhosalechinu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr sayaji Bapu desai |
| Designation |
Reader |
| Affiliation |
Yashwant Ayurvedic college post graduate training and research centre Kodoli |
| Address |
OPD NO.4 Shalya Tantra Department second floor Yashwant Ayurvedic college post Graduate training and Research centre Kodoli tal pahala dist kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9423282354 |
| Fax |
|
| Email |
drsayaji@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chinmay Bajarang Bhosale |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic college post graduate training and research centre Kodoli |
| Address |
OPD NO.4 Shalya Tantra Department second floor Yashwant Ayurvedic college post graduate training and research centre Kodoli tal
panhala dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8483836251 |
| Fax |
|
| Email |
bhosalechinu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic College post graduate training andresearch centre kodoli 416114 |
|
|
Primary Sponsor
|
| Name |
Dr Chinmay Bajarang Bhosale |
| Address |
Yashwant Ayurvedic medical college post graduate training and research centre kodoli 416114
|
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr chinmay bajarang bhosale |
Yashwant charitable hospital |
Casualty and OPD NO.4 Shalyatantra Department second floor Yashwant Ayurvedic college PGT and RC Kodoli tal pahala dist kolhapur 416114
Kolhapur
MAHARASHTRA |
8483836251
bhosalechinu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee Yashwant Ayurveda college PGT and RC Kodoli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:T149||Unspecified injury. Ayurveda Condition: SADYOVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Karpoor ghrita , Reference: Chakradatta , Route: Topical, Dosage Form: Ghrita, Dose: 10(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | | Silver colloid 10g topically once daily for 15 days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient having age between 20 to 60 years.
1 Patient having sign and symptoms of Abrasions having size
upto 6cm. will be randomly selected. Lacerated wound
upto 5cm×3cm×1cm
2 Ghrishta vrna(Abrasions)
3 Kshataj vrana(laceration)
4 Patients having both Ghrishta vrana (Abrasion) and Kshataj
vrana(Laceration)at once |
|
| ExclusionCriteria |
| Details |
Known cases of HIV, Hepatitis B, any systemic disease and any
known allergy
Patients suffering from wounds like
Chhinna vrana (Excised)
Bhinna vrana (Stab injury)
Viddha vrana (punctured)
Pichichita vrana.(crushed) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evalute the ropan effect that is the healing effect of Karpoor Ghrit in management of sadyovrana |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study the mode of action of karpoor ghrit
2.To study the mode of action
of silver colloid
3.To study etiopathology of sadyovrana in detail according to ayurved & different types of wound according to modern text.
4.To assess the improvement on the basis of subjective & objective parameters according to assessment criteria.
5.To achieve the outcome of study in 20 days |
20 days |
|
|
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)
|
20/06/2024 |
| 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
|
This is Randomized open controlled clinical study to asses the effect of karpoor ghrit as a ropan in management of sadhyovrana
First group (Trail Group) in which local application of karpoor ghrit as per required amount will be applied o er abrasion/laceration wound once daily for 15 days.
Second group (Control Group) in which local application of Silver colloid as per required amount will be applied over abrasion/laceration wound once daily for 15 days.
Evaluation pf ropan effect of both groups using statistical tools will be done and conclusion will be made.
|