| CTRI Number |
CTRI/2025/03/083545 [Registered on: 26/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EFFICACY OF KUTAJ KSHAR SUTRA LIGATION IN THE MANAGEMENT OF BHAGANDAR. |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY OF KUTAJ KSHAR SUTRA AND APAMARGA KSHAR SUTRA LIGATION IN THE MANAGEMENT OF BHAGANDAR WSR 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 Poorvi Pachouri |
| Designation |
PG Scholar |
| Affiliation |
Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal 462044 |
| Address |
OPD No.7 Shalya Tantra Department Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
8966080509 |
| Fax |
|
| Email |
poorvipachori19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajendra Kumar Dixit |
| Designation |
Associate Professor In Shalya Tantra Department |
| Affiliation |
Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal 462044 |
| Address |
OPD No.7 Shalya Tantra Department Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
9630765194 |
| Fax |
|
| Email |
drrajdixit14684@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Poorvi Pachouri |
| Designation |
PG Scholar |
| Affiliation |
Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal 462044 |
| Address |
OPD No.7 Shalya Tantra Department Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
8966080509 |
| Fax |
|
| Email |
poorvipachori19@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rani Dullaiya Smriti Ayurved P.G. College and Hospital ,Bhopal, MP,462044, INDIA. |
|
|
Primary Sponsor
|
| Name |
Dr Poorvi Pachouri |
| Address |
PG Scholar Shalya Tantra Department Rani Dullaiya Smriti Ayurved PG College And Hospital Bhopal,MP,462044,INDIA |
| 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 Poorvi Pachouri |
Rani Dullaiya Smriti Ayurved Hospital Bhopal |
OPD No.7 Shalya Tantra Department Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal
Bhopal
MADHYA PRADESH |
8966080509
poorvipachori19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Rani Dullaiya Smriti Ayurved PG College And Hospital Barkhedi Kalan Bhadbhada Road Bhopal |
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 | Drug | Classical | | (1) Medicine Name: KUTAJ, Reference: SHUSHRUTH SAMHITA, Route: Rectal, Dosage Form: Kshara , Dose: 1(NA), Frequency: sos, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: KSHAR SUTRA CHANGE EVERY 7TH DAY | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: APAMARGA, Reference: SHUSHRUTH SAMHITA, Route: Rectal, Dosage Form: Kshara , Dose: 120(mg), Frequency: sos, Bhaishajya Kal: Adhobhakta, Duration: 1 Weeks, anupAna/sahapAna: No, Additional Information: KSHAR SUTRA CHANGE EVERY 7TH DAY |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients suffering from Bhagandar(fissure-in- ano) with Symptomsinclude pain, swelling and discharge of pus from the anus.
2. low level fistula-in-ano
3. Patient within the age group of 20 to 60 years of age.
4. Patients will be selected irrespective of cast and religion, gender, habitat, occupationand socio- economic status. |
|
| ExclusionCriteria |
| Details |
1. Patients having Bhagandar (Fistula-in-Ano) secondary to known case ofUlcerative colitis, Crohn’s disease, Tuberculosis, Malignancy will be excluded.
2. High level fistula-in-ano
3. Patient below 20 years of age.
4. Patient with infective wound at anal region.
5. HIV and hepatitis B.
6. Uncontrolled diabetes mellitus
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Trail procedure is assessed for reduced pain,swelling,pus and fistulous tract after kshar sutra ligation |
21 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Trail procedure is assessed till the kshar sutra cuts through the tract completely. |
28 |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
10/04/2025 |
| 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="0"
Months="4"
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
|
Bhagandar[fistula-in-ano] is the
commonest anorectal condition seen in the day-to-day practice. The true
prevalence of fistula-in-ano is unknown. The incidence of a fistula-in-ano
developing from an anal abscess ranges from 26% to 38%.One study showed that
the prevalence of fistula-in-ano is 8.6 cases per 100,000 population.
Due to the adaptation of sedentary life
style in present Era the condition is still on the high prevalence worldwide.This
disease is recurrent in nature which makes it more difficult for treatment. KsharSutra
has been proved as a big revolution in the treatment of fistulainano. In many
studies, Apamargksharsutra is already proven to have best results in the
management of Bhagandar. It is the need to do further researches to get more
efficient ksharsutra.So we decided to study the efficacy of kutajkshar by
comparing it with the results of apamargkshar.
The qualities of Kutaj are kasay -Tikta Rasa, sheet Virya, Ruksha, Laghu, Tikshna Guna,. It has
Vranashodhan, Vranaropan property . •
Considering these properties of kutaj there may be less pain and better heal. |