| CTRI Number |
CTRI/2024/04/066194 [Registered on: 24/04/2024] Trial Registered Prospectively |
| Last Modified On: |
23/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Surgical/Anesthesia
Other (Specify) [KSHARASUTRA] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare efficacy of Nimba Ksharasutra and Apamarga Ksharasutra in the management of Bhagandara(Fistula-in-ano). |
|
Scientific Title of Study
|
Clinical study on Bhagandara(Fistula-in-ano) and its management with Nimba Ksharasutra. |
| 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 Satish Mishra |
| Designation |
MS Scholar |
| Affiliation |
Gopabandhu Ayurveda Mahavidyalaya VIP Road Puri |
| Address |
Post Graduate Department of Shalyatantra
Gopabandhu Ayurveda Mahavidyalaya
VIP Road Puri
Puri
ORISSA
752002
India |
| Phone |
7853001775 |
| Fax |
|
| Email |
drsatishmishra678@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Ranjan Kumar Kasta |
| Designation |
Professor & H.O.D |
| Affiliation |
Gopabandhu Ayurveda Mahavidyalaya VIP Road Puri |
| Address |
Post Graduate Department of Shalyatantra
Gopabandhu Ayurveda Mahavidyalaya
VIP Road Puri
Puri
ORISSA
752002
India |
| Phone |
9439809240 |
| Fax |
|
| Email |
drrkkasta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Ranjan Kumar Kasta |
| Designation |
Professor & H.O.D |
| Affiliation |
Gopabandhu Ayurveda Mahavidyalaya VIP Road Puri |
| Address |
Post Graduate Department of Shalyatantra
Gopabandhu Ayurveda Mahavidyalaya
VIP Road Puri
Puri
ORISSA
752002
India |
| Phone |
9439809240 |
| Fax |
|
| Email |
drrkkasta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gopabandhu Ayurveda Mahavidyalaya
VIP Road Puri Odisha India 752002 |
|
|
Primary Sponsor
|
| Name |
Dr Satish Mishra |
| Address |
Post Graduate Department of Shalyatantra
Gopabandhu Ayurveda Mahavidyalaya
VIP Road Puri Odisha India 752002 |
| 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 |
| Prof Dr Ranjan Kumar Kasta |
Gopabandhu Ayurveda Mahavidyalaya VIP Road Puri |
OPD & IPD Of Post Graduate Department of Shalyatantra
Puri
ORISSA |
9439809240
drrkkasta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Gopabandhu Ayurveda Mahavidyalaya & Hospital Puri Odisha 752002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K605||Anorectal fistula. Ayurveda Condition: BAGANDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | kShArasUtra, कà¥à¤·à¤¾à¤°à¤¸à¥‚तà¥à¤° | (Procedure Reference: Sushruta Samhita , Procedure details: Apllication of Nimba Ksharasutra in 30 patients of Bhagandara(Fistula-in-ano).The Ksharasutra will be changed after every 7 days,till it cut through the entire fistulous tract.)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All diagnosed cases of Bhagandara i.e. Low Anal Fistula. |
|
| ExclusionCriteria |
| Details |
Age below 20 years and above 60 years.
High Anal Fistula
Tuberculosis
Uncontrolled Hypertension
Uncontrolled Diabetes mellitus
Chronic or Acute Ulcerative colitis
Crohns disease
Ano rectal and other Malignancy
Veneral diseases, AIDS and Hepatitis B
Pregnancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To study the patho-physiology of Bhagandara.
2. To evaluate and assess the efficacy of the Nimba Ksharsutra in Fistula-in-Ano.
3. To introduce a less irritant,less pain and burning sensation,safe and best
alternative modality in the management of Bhagandara. |
The length of tract and other sign and symptoms will be assessed on 14th,28th,56th days respectively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The length of tract and other sign and symptoms will be assessed . |
14th,28th,56th days respectively. |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
06/05/2024 |
| 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="0"
Months="3"
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 A COMPARATIVE CLINICAL STUDY ON EFFICACY OF NIMBA KSHARASUTRA WITH APAMARGA KSHARASUTRA IN THE MANAGEMENT OF BHAGANDARA(FISTULA IN ANO). A. According to the procedure stated above 60 patients will be selected for the
study.
B. Selected case will be immediately undergo clinical examination and
pathological investigation to assess the presenting condition.
C. Out of 60 patients, 30 patients will be treated with Nimba ksharasutra and
categorized in Group-1 [G1].
D. Rest 30 patients will be treated with conventional Apamarga ksharasutra and
categorized in Group-2[G2]. |