| CTRI Number |
CTRI/2024/10/074800 [Registered on: 07/10/2024] Trial Registered Prospectively |
| Last Modified On: |
05/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see the effect of Snuhi-Apamarga kshar sutra and Guggulu -Nimba kshar sutra in Bhagandara(Fistula-in-ANO) |
|
Scientific Title of Study
|
Comparative clinical evaluation of Snuhi-Apamarga kshar sutra and Guggulu -Nimba kshar sutra in Bhagandara(Fistula-in-ANO) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anuj |
| Designation |
PG Scholar |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD 15, Department of Shalya-Tantra, Patanjali ayurved hospital,Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Phase 1, Roorkee road, Haridwar, Uttarakhand, India 249405
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7988801451 |
| Fax |
|
| Email |
naraanuj58@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Sachin Gupta |
| Designation |
HOD & Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD 15, Department of Shalya-Tantra, Patanjali ayurved hospital,Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Phase 1, Roorkee road, Haridwar, Uttarakhand, India 249405
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9419135050 |
| Fax |
|
| Email |
chintu.925@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anuj |
| Designation |
PG scholar |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD 15, Department of Shalya-Tantra, Patanjali ayurved hospital,Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Phase 1, Roorkee road, Haridwar, Uttarakhand, India 249405
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7988801451 |
| Fax |
|
| Email |
naraanuj58@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Yogpeeth Phase1, Roorkee road, Haridwar, Uttarakhand, India 249405 |
|
|
Primary Sponsor
|
| Name |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan,
Haridwar, Uttarakhand, India 249405 |
| 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 Anuj |
Patanjali Ayurvedic Hospital |
Opd 15, Department of Shalya Tantra , Patanjali Ayurved Hospital,Haridwar
Hardwar
UTTARANCHAL |
7988801451
naraanuj58@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee patanjali ayurved hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K928||Other specified diseases of the digestive system. 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: चकà¥à¤°à¤¦à¤¤à¥à¤¤ अरà¥à¤¶à¥‹à¤§à¤§à¤•à¤¾à¤° ५/१४८ , सà¥.सू. ११/१२ , Procedure details: Snuhi-Apamarga kshar sutra ligation locally in fistula tract & changed weekly till the whole tract is completely cut through (duration of treatment depends upon length of fistula tract))
)
| | 2 | Comparator Arm | Procedure | - | kShArasUtra, कà¥à¤·à¤¾à¤°à¤¸à¥‚तà¥à¤° | (Procedure Reference: चकà¥à¤°à¤¦à¤¤à¥à¤¤ अरà¥à¤¶à¥‹à¤§à¤§à¤•à¤¾à¤° ५/१४८ , सà¥.सू. ११/१२ , Procedure details: Guggulu-Nimba kshar sutra ligation locally in fistula tract & changed weekly till the whole tract is completely cut through (duration of treatment depends upon length of fistula tract))
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient age ranging between 18 - 60 years
Clinical Signs and Symptoms of all types of Bhagandara.
Patient diagnosed as well as recurrent cases of Fistula in -Ano |
|
| ExclusionCriteria |
| Details |
• HBsAg, HCV and HIV positive patients.
• Secondary fistulas due to: -
1. Crohn’s disease
2. Ulcerative colitis
3. Carcinoma of Rectum
4. Pelvic Abcess
5. Tuberculosis
6. Osteomyelitis of Pelvic Bone.
7. Patient having uncontrolled
Diabetes and Hypertension.
8. Other systemic disorder. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective Parameters–
Itching
Burning sensation
Discharge
Pain
Inflammation
Objective parameters-
unit cutting time
|
Assessment will be done at baseline, followed by weekly assessment until the fistula tract is completely healed
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Subjective Parameters-
Itching
Burning sensation
Discharge
Pain
Inflammation
|
upto 3 Months after cut through of the fistula tract |
|
|
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 2 |
|
Date of First Enrollment (India)
|
16/10/2024 |
| 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
|
In this trial we are selecting patients of Bhagandara (Fistula-in-Ano) and dividing them into two groups with 30 patients in each group. In 1st group, we will do intervention with standard Snuhi-Apamarga kshar sutra ligation of fistula tract and in 2nd group, we will do intervention with Guggulu- Nimba kshar sutra ligation of fistula tract. Comparative study to be done on the basis of assessment based on subjective and objective parameters. Subjective parameters includes Burning sensation , Itching, Discharge, Pain and Inflammation and Objective parameters includes unit cutting time |