| CTRI Number |
CTRI/2024/12/077896 [Registered on: 10/12/2024] Trial Registered Prospectively |
| Last Modified On: |
09/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Interventional] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of trivruttyadi malahara in post operative fistulectomy wound in comparison of placentrex gel |
|
Scientific Title of Study
|
Effect Of Trivruttyadi Malahara And Placentrex Gel On Granulation Formation (Utsadana) In The Management Of Post Operative Fistulectomy Wound : A Randomized Controlled Trial |
| 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 Shubhangi Somnath Birdawade |
| Designation |
PG Scholar |
| Affiliation |
Shri Ayurved Mahavidyalaya,Nagpur |
| Address |
Opd No.7,Shalyatantra Department, Pakwasa Samanvay Rugnalaya,Shri Ayurved Mahavidyalaya,Hanuman Nagar Nagpur ,Dhanwantari Marga,Nagpur Maharashtra 440024 Nagpur
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9130054126 |
| Fax |
|
| Email |
shubhangibirdawade6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti Pradeep Dalal |
| Designation |
HOD And Professor Of Shalya Tantra |
| Affiliation |
Shri Ayurved Mahavidyalaya,Nagpur |
| Address |
Opd No.7,Shalyatantra Department, Pakwasa Samanvay Rugnalaya,Shri Ayurved Mahavidyalaya,Hanuman Nagar Nagpur ,Dhanwantari Marga,Nagpur Maharashtra 440024 Nagpur
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9975830051 |
| Fax |
|
| Email |
drjyoti.dalal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubhangi Somnath Birdawade |
| Designation |
PG Scholar |
| Affiliation |
Shri Ayurved Mahavidyalaya,Nagpur |
| Address |
Opd No.7,Shalyatantra Department, Pakwasa Samanvay Rugnalaya,Shri Ayurved Mahavidyalaya,Hanuman Nagar Nagpur ,Dhanwantari Marga,Nagpur Maharashtra 440024 Nagpur
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9130054126 |
| Fax |
|
| Email |
shubhangibirdawade6@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shalyatantra department,Pakwasa samanway rugnalaya,Shri Ayurved Mahavidyalaya, Hanuman nagar, Nagpur, 440024 |
|
|
Primary Sponsor
|
| Name |
Shri Ayurved Mahavidyalaya,Nagpur |
| Address |
Pakwasa Samanway Rugnalaya,Hanuman Nagar,Dhanwantari Marga,Nagpur 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 |
| DrShubhangi Somnath Birdawade |
Shri Ayurved Mahavidyalaya,Nagpur |
Opd No.7 Shalyatantra Department ,Pakwasa Samanway Rugnalaya, Shri Ayurved Mahavidyalaya,Hanuman Nagar,Dhanwantari Marga , Nagpur,Maharashtra 440024
Nagpur
MAHARASHTRA |
9130054126
shubhangibirdawade6@gmail.com |
|
|
Details of Ethics Committee
|
| 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:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: BAGANDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Placentrex gel | Placenta extract belongs to the group of medicine called human derived ingredients.It works by increasing blood flow and level of certain proteins .This promotes tissue regeneration. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Trivruttyadi malahara, Reference: Su.chi 8/40, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients with post operative fistulectomy wound
(Low anal single tract fistula with tract length less than or equal to 6 cm)
2)The patients from the age group 18 to 50 years irrespective of gender, religion, occupation, education, and socio- economic status. |
|
| ExclusionCriteria |
| Details |
1)Patients having uncontrolled Diabetes Mellitus and Hypertension
2) Patient with Secondary fistula in ano. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evalutaion of efffect of Trivruttyadi Malahara in management of post- operative fistulectomy wound healing. |
At the end of 21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Trivruttyadi Malahara is more effective than Placentrex gel |
At the end of 21 days |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
21/12/2024 |
| 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 study will be carried out at opd of shalyatantra of Pakwasa Samanvay Rugnalaya, Nagpur .This is an open label randomized controlled trial aims at studying the comparison between Trivruttyadi malahara and placentrex gel in the management of post operative fistulectomy wound with special reference of granulation formation. Total 76 patients will be included and will be randomly divided into two groups i.e. Group A and Group B each containing 38 patients. Group A will be trial group where patients will receive application of Trivruttyadi Malahara and Group B will be control group will receive application of Placentrex Gel. 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. |