| CTRI Number |
CTRI/2024/04/065320 [Registered on: 05/04/2024] Trial Registered Prospectively |
| Last Modified On: |
02/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Taila pooran ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of Efficacy of bhagandarvinashan tail pooran in bhagandar wsrt fistula in ano. |
|
Scientific Title of Study
|
Assessment of efficacy of Bhagandar vinashan taila pooran in Bhagandar |
| 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 Tazeen Choudhary |
| Designation |
PG Scholar |
| Affiliation |
Dr G D Pol foundation Y M T Ayurvedic medical college and hospital |
| Address |
3rd floor,Shalya tantra department,Dr G D Pol foundation Y M T Ayurvedic medical college and hospital PG Institute Sector 4 Kharghar Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9967059252 |
| Fax |
|
| Email |
choudharytazeen1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjeev Yadav |
| Designation |
Professor |
| Affiliation |
Dr G D Pol foundation Y M T Ayurvedic medical college and hospital |
| Address |
3rd floor,Shalya tantra department,Dr G D Pol foundation Y M T Ayurvedic medical college and hospital PG Institute Sector 4 Kharghar Navi Mumbai
MAHARASHTRA
410210
India |
| Phone |
9322456999 |
| Fax |
|
| Email |
drsanjeevyadav22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tazeen Choudhary |
| Designation |
PG Scholar |
| Affiliation |
Dr G D Pol foundation Y M T Ayurvedic medical college and hospital |
| Address |
3rd floor,Shalya tantra department,Dr G D Pol foundation Y M T Ayurvedic medical college and hospital PG Institute Sector 4 Kharghar Navi Mumbai
MAHARASHTRA
410210
India |
| Phone |
9967059252 |
| Fax |
|
| Email |
choudharytazeen1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr G D Pol foundation YMT Ayurvedic medical college and Hospital PG institute sector 4 kharghar Navi Mumbai Maharashtra 410210
India. |
|
|
Primary Sponsor
|
| Name |
Tazeen Choudhary |
| Address |
Dr G D Pol foundation YMT Ayurvedic medical college and Hospital PG institute sector 4 kharghar Navi Mumbai |
| 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 Tazeen Choudhary |
Dr G D pol foundation YMT ayurvedic medical college and hospital PG Institute |
405,505,4th and 5th floor,Dr G D pol foundation YMT ayurvedic medical college and hospital PG Institute sector 4 kharghar Navi Mumbai 410210
Raigarh
MAHARASHTRA |
9967059252
choudharytazeen1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 | Intervention Arm | Procedure | - | pUraNa-karma, पूरण-करà¥à¤® | (Procedure Reference: Sushruta samhita chikitsa sthana 8/43-46, Procedure details: Under AAP Probe have been inserted into Tract to find Bhagandar nadi Then bhagandar nashan tail Taken in a syringe Use to draw taila Pooran & instilled through blunt needle in bhagandar nadi followed by packing with gauze and dressing.
Patient will observe daily for 14 days then follow up of patient will be on 21 st day.
)
(1) Medicine Name: Bhagandarvinashan , Reference: Sushruta samhita chikitsa sthana 8/43-46, Route: Topical, Dosage Form: Taila, Dose: 3(ml), Frequency: od, Duration: 14 Days |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patient suffering from Fistula in ano specially Of low level type
Patient irrespective of age and sex have been included
|
|
| ExclusionCriteria |
| Details |
Complex fistula in ano High level fistula in ano
Multiple fistula in ano
patient with HIV HBsAg positive
Other systemic disorder
Fistula developing secondary to disease like Ulcerative colitis crohns disease
Tuberculosis malignancy uncontrolled DM etc
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
SUBJECTIVE
Pain (Absent/Present )
Tenderness(Absent/Present)
Itching (Absent/Present)
OBJECTIVE
1-Length of track
Grade 0 – Absence of track
Grade 1 – upto 1 cm of track.
Grade 2 – upto 2 cm of track.
Grade 3 – upto 3 cm of track.
2-Discharge
Grade 0- No Discharge
Grade 1- Serous Discharge
Grade 2- Serosanguinous Discharge
Grade 3- Sanguinous Discharge
Grade 4- Purulent Discharge.
|
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To avoid use of antibiotics for long duration & long recovery time
To prevent infection
and incontinence |
Continue for 14 days then on 21st day
|
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
15/04/2024 |
| 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="0"
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
|
To assess the effect of bhagandarvinasha taila pooran in bhagandar wsrt fistula in ano for 21 days Sample size 48 Subjective criteria Pain (Absent/Present )
Tenderness(Absent/Present)
Itching (Absent/Present)
Objective criteria 1 Length of track
• Grade 0 – Absence of track
• Grade 1 – upto 1 cm of track.
• Grade 2 – upto 2 cm of track.
• Grade 3 – upto 3 cm of track.
2 Discharge
• Grade 0- No Discharge
• Grade 1- Serous Discharge
• Grade 2- Serosanguinous Discharge
• Grade 3- Sanguinous Discharge
• Grade 4- Purulent Discharge.
|