| CTRI Number |
CTRI/2025/03/083713 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ksharasutra therapy In Fistula In Ano |
|
Scientific Title of Study
|
Comparative Clinical Study In Fistula In Ano To Evaluate The Efficacy Of Ultramodern Mechanised Ksharasutra Thread And Traditional Ksharasutra Thread |
| 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 Kamal Anilbhai Patel |
| Designation |
PG Scholar |
| Affiliation |
|
| Address |
Room No 403
Department Of Shalya Tantra,
Parul Institute Of Ayurved,
Parul University,
Post Limda,
Waghodia,
Gujarat 391760
Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9408094493 |
| Fax |
|
| Email |
kamalpatel11101998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemant Toshikhane |
| Designation |
Professor |
| Affiliation |
|
| Address |
Room No 403
Department Of Shalya Tantra,
Parul Institute Of Ayurved,
Parul University,
Post Limda,
Waghodia,
Gujarat 391760
Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
8469496525 |
| Fax |
|
| Email |
drhemantt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemant Toshikhane |
| Designation |
Professor |
| Affiliation |
|
| Address |
Room No 403
Department Of Shalya Tantra,
Parul Institute Of Ayurved,
Parul University,
Post Limda,
Waghodia,
Gujarat 391760
Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
8469496525 |
| Fax |
|
| Email |
drhemantt@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD NO 106
Parul Ayurved Haopital
Limda
Vadodara
Gujarat
India
391760
|
|
|
Primary Sponsor
|
| Name |
Dr Kamal Anilbhai Patel |
| Address |
OPD No 106
Department Of Shalya Tantra
Parul Institute Of Ayurved
Parul University
At Limda
Vadodara
Gujarat
India
391760 |
| 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 Kamal Anilbhai Patel |
Parul Ayurved Hospital |
OPD No 106
Department Of Shalya Tantra
Parul Institute Of Ayurved
Parul University
At Limda
Vadodara
Vadodara
GUJARAT |
9408094493
kamalpatel11101998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul Institute Of Ayurved |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K603||Anal fistula. Ayurveda Condition: BAGANDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | kShArasUtra, क्षारसूत्र | (Procedure Reference: , Procedure details: PURVAKARMA
Procedure will be explained to the patient.
NBM For 6 Hours In Spinal Anesthesia
Written Consent will be taken.
PC Enema Will Be Given Before 1 Hour of Procedure.
Injection Tetanus Toxoid 0.5 ml IM
Xylocaine Sensitivity Test 0.2 ml ID
PRADHANKARMA
Under all aseptic precautions & Appropriate anesthesia, patient will be given lithotomy position.
Part painting & draping will be done.
Anal Dilatation will be carried out If required.
Patency of Fistula tract will be done.
Probing of The Fistula will be done gently to identify any external & internal opening.
In patients of both group A & group B, first partial fistulectomy will be done & then after,
Ksharasutra will be applied in remaining part of the fistulous tract.
After achieving hemostasis, sterile dressing will be done & patient will be shifted to recovery
room.
PASCHATKARMA
NBM for 6 hours.
Antibiotic, Antacid, Analgesic will be given If required.
Wound Care Instruction to the patient on proper wound care, including keeping the area clean & dry will be given.
)
| | 2 | Comparator Arm (Non Ayurveda) | | - | Ksharasutra Device | Ksharasutra thread will make by using Ultramodern Mechanised Ksharasutra Device.
The process of preparation of ksharasutrais done inside a specially designed cabinet having arrangement for heating assembly for drying and LED ultraviolet light for sterilization.
In this process we use uniform mixture of Apamarga Kshara, haridra churna and Guggulu Niryasa in coating assembly.
The linen is passed through coating assembly where coat of the mixture will be uniformly applied on thread.
The blower in heating assembly dries the thread completely and simultaneously then passed into a tunnel lighted with ultra violet light.
Then thread is cut.
Then suitable pieces of thread are packed in sterile condition.
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinical signs & symptoms of Bhagandara [Low Anal Fistula]
Age: Between 20 to 60 years.
Fistula track not exceeding 3 cm in length.
Single Track Fistula
|
|
| ExclusionCriteria |
| Details |
Age: Below 20 & Above 60 years.
High Anal Fistula.
Diabetic Patients.
HIV+ve, HBsAg+ve, VDRL+ve.
Secondary Fistula due to: i. Ulcerative colitis, ii. Chron’s disease, iii. Tuberculosis,
iv. Carcinoma of Rectum & Anal canal.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief from pain, pus discharge |
72 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief from swelling, itching |
72 days |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
11/04/2025 |
| 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="2"
Months="0"
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
|
Aim To comparatively evaluate the efficacy of two different types of Ksharasutra threads - Mechanised Ksharasutra and Traditional Ksharasutra-in the management of fistula-in-ano.
Objectives Primary Objectives To evaluate the efficacy of Ultramodern Mechanised Ksharasutra in the management of Fistula-in-Ano. To evaluate the efficacy of Traditional Ksharasutra in the management of Fistula-in-Ano.
Secondary Objectives Assessment of Pain, Discharge, Itching and Swelling as subjective parameters. Assessment of Unit Cutting Time (UCT) as an objective parameters.
Null Hypothesis (H0) Ultramodern Mechanised Ksharasutra will not be Efficacious in healing of Fistula-in Ano as compared to Traditional Ksharasutra.
Alternate Hypothesis (H1) Ultramodern Mechanised Ksharasutra will be equally efficacious in healing of Fistula-in-Ano as compared to Traditional Ksharasutra.
Alternate Hypothesis (H2) Ultramodern Mechanised Ksharasutra will be more efficacious in healing of Fistula-in-Ano as compared to Traditional Ksharasutra.
|