| CTRI Number |
CTRI/2024/09/073618 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
10/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
HEALING EFFECT OF KAMPILLAKA TAILA OVER JATYADI TAILA IN MANAGEMENT OF SADYOVRANA |
|
Scientific Title of Study
|
Randomized Controlled Trial Of Kampillaka Taila In Comparison With Jatyadi Taila In Wound Healing W.S.R To Sadyovrana |
| 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 Sandipa Gangadhar Channawar |
| Designation |
PG Scholar |
| Affiliation |
Shri Ayurved Mahavidyalaya |
| Address |
OPD NO 7,Shalyatantra Department,Pakwasa Samanvay Rugnalaya,Shri Ayurved Mahavidyalaya,Hanuman Nagar,Dhanwantari Marga,Nagpur
Maharashtra
440024
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9321256290 |
| Fax |
|
| Email |
sandipachannawar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandesh Santosh Khobragade |
| Designation |
Associate Professor |
| Affiliation |
Shri Ayurved Mahavidyalaya |
| Address |
OPD NO 7,Shalyatantra Department,Pakwasa Samanvay Rugnalaya,Shri Ayurved Mahavidyalaya,Hanuman Nagar,Dhanwantari Marga,Nagpur
Maharashtra
440024
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9987014379 |
| Fax |
|
| Email |
drsandesh1128@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandipa Gangadhar Channawar |
| Designation |
PG Scholar |
| Affiliation |
Shri Ayurved Mahavidyalaya |
| Address |
OPD NO 7,Shalyatantra Department,Pakwasa Samanvay Rugnalaya,Shri Ayurved Mahavidyalaya,Hanuman Nagar,Dhanwantari Marga,Nagpur
Maharashtra
440024
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9321256290 |
| Fax |
|
| Email |
sandipachannawar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Ayurved Mahavidyalaya Pakwasa Samanvay Rugnalaya Hanuman Nagar Dhanwantari Marga Nagpur Maharashtra 440024 |
|
|
Primary Sponsor
|
| Name |
Shri Ayurved Mahavidyalaya |
| Address |
Pakwasa Samanvay Rugnalaya,Shri Ayurved Mahavidyalaya,Hanuman Nagar,Dhanwantari Marga,Nagpur
Maharashtra
440024 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sandipa Gangadhar Channawar |
Shri Ayurved Mahavidyalaya |
OPD NO 7,Shalyatantra Department,Pakwasa Samanvay Rugnalaya,Shri Ayurved Mahavidyalaya,Hanuman Nagar,Dhanwantari Marga,Nagpur
Maharashtra
440024
Nagpur
MAHARASHTRA |
9321256290
sandipachannawar@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC of Shri Ayurved Mahavidyalaya |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: SADYOVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kampillaka Taila, Reference: Charaksamhita Chikitsasthan , Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 21 Days, Reference: No, Route: NA, Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Jatyadi Taila, Reference: Sharangdhar Samhita Madhyamkhand, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 21 Days, Reference: No, Route: NA, Dosage Form: Taila, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients from the age group 18-60 years irrespective of gender, religion, occupation, educational and socio-economic status.
2) Patients diagnosed with Sadyovrana.
3)Wound length upto 5 cm
And width upto 5 cm
|
|
| ExclusionCriteria |
| Details |
1)Patients suffering from Malignant ulcers, Syphilitic ulcers , Lepromatous ulcer ,diabetic wound and Tubercular ulcers will be excluded from the study.
2) Patients having history of bleeding disorders and anaemia having haemoglobin % less than 6 gm
3)Immuno -compromised patients like syphilis, HIV, HBsAg positive
4) Patients diagnosed with Dushtavrana.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
This study may provide use of Kampillaka Taila as conservative treatment option for Sadyovrana.
|
At the end of 21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
comparative effect of healing between kampillaka taila and jatyadi taila in sadyovrana will be assessed
|
At the end of 21 days |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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 3 |
|
Date of First Enrollment (India)
|
18/09/2024 |
| 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 Yet Recruiting |
| 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 study will be carried out at opd of shalyatantra of Pakwasa Samnvay Rugnalaya ,Nagpur .This is an open label randomized controlled trial aims at studying the comparison between wound healing effect of Kamipillak Taila and jatyadi taila in sadyovrana patients.Total 64 patients will be included and will be randomly divided into two groups i.e. Group A and Group B each containing 32 patients.Group A will be trial group where patients will receive application of Kampillaka Taila and Group B will be control group will receive application of jatyadi taila.Then patients will be observed on 7th,14th and 21st day.All the findings will be recorded in case record form,At the end of trial,collected data will be analyzed and result will be drawn accordingly.
|