| CTRI Number |
CTRI/2025/02/081226 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
22/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Application of Guggulu kshara sutra in fistula in ano (Bhagandra) |
|
Scientific Title of Study
|
Randomized controlled clinical study to evaluate the efficacy of Guggulu kshara sutra in the management of Bhagandra w.s.r. to fistula in ano |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yatendra kumar |
| Designation |
MS PG scholar |
| Affiliation |
Vaidya yagya Dutt Sharma ayurved mahavidyalaya. Khurja Bulandshahr |
| Address |
OPD NO 5 Shayla Tantra department ,Vaidya Yagya Dutt Sharma Ayurved Mahavidhyalya PLRD Hospital Khurja Bulandshahar
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
8433411065 |
| Fax |
|
| Email |
Yatendrakumar6573@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Mishra |
| Designation |
Professor Of Shalya tantra department |
| Affiliation |
Vaidya yagya dutt Sharma Ayurved mahavidhyalaya Khurja Bulandshahar |
| Address |
OPD NO 5 Shayla Tantra department ,Vaidya Yagya Dutt Sharma Ayurved Mahavidhyalya PLRD Hospital Khurja Bulandshahar
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
9838325000 |
| Fax |
|
| Email |
dramitkjjftp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Mishra |
| Designation |
Professor Of Shalya tantra department |
| Affiliation |
Vaidya yagya dutt Sharma Ayurved mahavidhyalaya Khurja Bulandshahar |
| Address |
OPD NO 5 Shayla Tantra department ,Vaidya Yagya Dutt Sharma Ayurved Mahavidhyalya PLRD Hospital Khurja Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
9838325000 |
| Fax |
|
| Email |
dramitkjjftp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vaidya yagya Dutt Sharma ayurved Mahavidyalaya khurja Bulandshahr |
|
|
Primary Sponsor
|
| Name |
Dr Yatendra Kumar |
| Address |
OPD NO -5 Shalya Tantra department Vaidya Yagya Dutt Sharma ayurved Mahavidyalaya, PLRD Hospital khurja Bulandshahr, Uttar Pradesh |
| 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 Yatendra Kumar |
Vaidya yagya Datt Sharma ayurved mahavidyalaya and hospital khurja bulandshahr uttar pradesh |
OPD NO-5 SHALYA TANTRA DEPARTMENT VAIDYA YAGYA DUTT SHARMA AYURVED MAHAVIDYALAYA PLRD HOSPITAL KHURJA BULANDSHAHR UTTAR PRADESH
Bulandshahar
UTTAR PRADESH |
8433411065
yatendrakumar6573@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee vaidya yagya dutt sharma ayurved mahavidyalaya khurja bulandshahr uttar pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fistula in ano |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | kShArasUtra, क्षारसूत्र | (Procedure Reference: Sushrut samhita nidan sthan 4/4, Procedure details: Ligation of Guggulu ksharsutra every weekly)
|
|
|
|
Inclusion Criteria
|
| Age From |
17.00 Day(s) |
| Age To |
60.00 Day(s) |
| Gender |
Both |
| Details |
1 The Patient who presented with the signs & symptoms Bhagandra w.s.r fistula in ano. 2 Patient having age between 18 to 60 year 3 Fistulous tract less than 3cm .(1.5inch)will be included.
|
|
| ExclusionCriteria |
| Details |
1.Patient aged below 16 and above 60 year of age 2. Patient who are sensitive to xylocaine will be excluded. 3. Sedentary lifestyle disorder like uncontrolled hypertension, uncontrolled diabetes mellitus , ulcerative colitis, crohn disease,Fistula with high level fistula with multiple opening will be excluded, Osteomyelitis of hip bone ,HIV HBsAg and rectal malignancy |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of Guggulu kshara sutra to relieve the fistula in ano |
To evaluate the effect of Guggulu kshara sutra to relieve the fistula in ano |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effective as well as curative management for this painful condition |
After analysing all parameters the result will be assessed on the basis of symptomatic relief and improvement
Fair recovery after 4 week important in clinical features 31 to 60 percent
Good recovery important after 6 week important in clinical features 60 to 90 percent complete recovery after 8 weeks important in clinical features more than 90 percent |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
05/03/2025 |
| 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="0"
Months="9"
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 sushrut samhita nidan sthan chepter 4/4 it is mentioned Aachary sushruta has described that bhagandra is usually secondary to the pidika of gudapradesh. When bhagandra pidika further get suppurated and burst out due to excessive vitiation of doshas,this leads to the formation of the bhagandra. Hence the bhagandra can be defined as a pathological conditions which causes tear and pain in the anorectal canal , vagina or urinary bladder. In charaka samhita chikitsa sthan it is mentioned chapter 12 of shotha chikitsa under the disease bhandara occuring in the anorectal region charaka has given a little description about bhagandra. Acharya Vagbhatt explained etiological factor of Bhagandra as following verses. Chepter 28 /1-2) |