| CTRI Number |
CTRI/2024/12/078178 [Registered on: 16/12/2024] Trial Registered Prospectively |
| Last Modified On: |
12/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
CLINICAL TRIAL TO UNDERSTAND MEDICINAL PROPERTIES OF ASHMANTAK KNOWN AS APTA HERBAL SUTURE MATERIAL USED IN INCISED WOUND |
|
Scientific Title of Study
|
RANDOMISED CLINICAL CONTROLLED TRIAL TO EVALUATE THE EFFICACY OF ASHMANTAK NON ABSORBABLE POLYFILAMENT SUTURE MATERIAL IN THE TREATMENT OF KSHATA VRANA |
| 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 PRIYANKA POPAT CHAVAN |
| Designation |
PG SCHOLAR |
| Affiliation |
PG SCHOLAR |
| Address |
HON SHRI ANNASAHEB DANGE AYURVED MEDICAL COLLEGE POST GRADUATE AND RESEARCH CENTER ASHTA TAL WALWA
HON SHRI ANNASAHEB DANGE AYURVED MEDICAL COLLEGE POST GRADUATE AND RESEARCH CENTER ASHTA TAL WALWA
Sangli
MAHARASHTRA
416301
India |
| Phone |
8983525428 |
| Fax |
|
| Email |
pchavan10698@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VD AKBAR WALANDKAR |
| Designation |
PROFESSOR |
| Affiliation |
HON SHRI ANNASAHEB DANGE AYURVED MEDICAL COLLEGE POST GRADUATE AND RESEARCH CENTER ASHTA |
| Address |
DEPT OF SHALYA TANTRA
HON SHRI ANNASAHEB DANGE AYURVED MEDICAL COLLEGE POST GRADUATE AND RESEARCH CENTER ASHTA TAL WALWA
Sangli
MAHARASHTRA
416301
India |
| Phone |
9860181980 |
| Fax |
|
| Email |
akbar.walandkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
VD AKBAR WALANDKAR |
| Designation |
PROFESSOR |
| Affiliation |
HON SHRI ANNASAHEB DANGE AYURVED MEDICAL COLLEGE POST GRADUATE AND RESEARCH CENTER ASHTA |
| Address |
DEPT OF SHALYA TANTRA
HON SHRI ANNASAHEB DANGE AYURVED MEDICAL COLLEGE POST GRADUATE AND RESEARCH CENTER ASHTA TAL WALWA
Sangli
MAHARASHTRA
416301
India |
| Phone |
9860181980 |
| Fax |
|
| Email |
akbar.walandkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| HON SHRI ANNASAHEB DANGE AYURVED MEDICAL COLLEGE POST GRADUATE AND RESEARCH CENTER
ASHTA TAL-WALWA DIST- SANGLI 416 301 |
|
|
Primary Sponsor
|
| Name |
VD PRIYANKA POPAT CHAVAN |
| Address |
SHALYA OPD NO 13 DHANWANTARI AYURVED HOSPITAL ASHTA |
| 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 |
| VD PRIYANKA CHAVAN |
VD PRIYANKA CHAVAN |
HON SHRI ANNASAHEB DANGE AYURVED MEDICAL COLLEGE ASHTA SANGALI
Sangli
MAHARASHTRA |
8983525428
pchavan10698@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HON SHRI ANNASAHEB DANGE AYURVED MEDICAL COLLEGE POST GRADUATE AND RESEARCH CENTER ASHTA INSTITUTIONAL ETHICAL COMITTEE |
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: KSHATAHÂ NIPATITA-SADYOVRANAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | ETHILON 3-0 | ETHILON Suture is a nonabsorbable, sterile surgical monofilament suture composed of the long-chain aliphatic polymers made of polyamide 6 which are Nylon 6 and Nylon 6,6. ETHILON Suture is dyed black or green to enhance visibility in tissue.Â
ETHILON Suture is indicated for use in general soft tissue approximation and/or ligation
| | 2 | Intervention Arm | Procedure | - | sIvanam, सीवनमॠ| (Procedure Reference: SUSHRUT SAMHITA SUTRASTHAN CHAPTER 25,, Procedure details: 1. WRITTEN INFORMED CONSENT SHOULD BE TAKEN FROM PATIENT 2. LOCAL ANESTHESIA SHOULD BE GIVEN .PAINTING, DREPPING SHOULD BE DONE 3. SUTURE TAKEN WITH ASHMANTAK (APTA) HERBAL SUTURE MATERIAL 4.DRESSING DONE)
|
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.PATIENT WITH SIMPLE INCISED WOUND
2.PATIENT WITH SUPERFICIAL LACERETED WOUND
3.ALL PRIKRITI PATIENTS HAVING WOUND
4.PATIENT WITH HAVING WOUND APPROXIMATELY 7 CM
PATIENTS WITH ROAD TRAFFIC ACCEDENTAL WOUND WITH REGULAR MARGIN |
|
| ExclusionCriteria |
| Details |
1.PATIENTS WITH PENETRATING WOUND
2.PATIENTS WITH CRUSHED INJURY
3.MAJOR SURGERY
PATIENTS WITH HAEMOPHILIC DISORDER |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.TO OBSERVE THE TENSILE STRENGTH OF ASHMANTAK FIBRE AT VARIOUS STAGE OF WOUND HEALING
2. TO PREPARE IT AN ACCEPTABLE HERBAL SUTURING MATERIAL AND STUDY ITS PROPERTIES
3.TO DETERMINE DIAMETER OF ASHMANTAK FIBRE |
0TH , 2ND DAY , 4TH DAY , 6TH DAY , 8TH DAY , 10NTH DAY
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.TO OBSERVE HAEMOSTATIC PROPERTY OF ASHMANTAK
2. TO OBSERVE THE MERIT AND DEMERIT AS SUTURING MATERIAL AND COMPARE WITH ETHILON 3.0 |
0TH , 2ND DAY , 4TH DAY , 6TH DAY , 8 TH DAY , 10 TH DAY |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
06/01/2025 |
| 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
|
The prevalence rate of traumatic injury is approx 60-70% as per ideal treatment open wound should be ligated first and most importantly bleeding should be stopped as for the primary treatment of CLW synthetic non absorbabe suture material such as ethilon , prolene is used which cost 300-400 RS , which is not affordable to every patients
Acharya sushrut stated Ashtavidha shashtrakarma in which seevan karma is used in Kshta vran (incised wound ) . Acharya sushruta mentioned shan ,moorva ,guduchi pratan ,ashmantak as non absorbable suture material and Snayu taan as Absorbale suture material Ashmantak which is known as Apta is easily available in india Ashmantak has great tensile strength as well as wound healing properties.
In this study I will observe and determine the diameter of Ashmantak suture material , tensile strength ,and its medicinal property , Through this study I will make it acceptable Herbal suture material which will cost effective to patients |