| CTRI Number |
CTRI/2023/08/056968 [Registered on: 28/08/2023] Trial Registered Prospectively |
| Last Modified On: |
17/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical study to compare the effect of modified apamarga kshaara sutra and standard apamarga kshaarasutra in the management of bhagandara (fistula-in-ano) |
|
Scientific Title of Study
|
Comparative clinical study on the effect of modified Apamarga Kshaarasutra and standard Apamarga Kshaarasutra in the management of 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 |
Dr Saurabh Kumar Yadav |
| Designation |
Pg scholar- Department of Shalyatantra |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan |
| Address |
Sri Dharmasthala Manjunatheshwara
College Of ayurveda And Hospital B.M Road Thanniruhalla Hassan Karnataka – 573201
Hassan
KARNATAKA
573201
India |
| Phone |
6360271762 |
| Fax |
|
| Email |
ysaurabh920@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Kumar ES |
| Designation |
Associate Professor- Department of Shalyatantra |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan |
| Address |
Sri Dharmasthala Manjunatheshwara
College Of ayurveda And Hospital B.M Road Thanniruhalla Hassan Karnataka – 573201
Hassan
KARNATAKA
573201
India |
| Phone |
8073851473 |
| Fax |
|
| Email |
drmaheshkumar@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahesh Kumar ES |
| Designation |
Associate Professor- Department of Shalyatantra |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan |
| Address |
Sri Dharmasthala Manjunatheshwara
College Of ayurveda And Hospital B.M Road Thanniruhalla Hassan Karnataka – 573201
Hassan
KARNATAKA
573201
India |
| Phone |
8073851473 |
| Fax |
|
| Email |
drmaheshkumar@sdmcahhassan.org |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara
College Of ayurveda And Hospital B.M Road Thanniruhalla Hassan Karnataka – 573201 |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan |
| Address |
Sri Dharmasthala Manjunatheshwara
College Of ayurveda And Hospital B.M Road Thanniruhalla Hassan Karnataka – 573201 |
| Type of Sponsor |
Private medical college |
|
|
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 Saurabh Kumar Yadav |
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital Hassan |
Department of Shalyatantra OPD-no-11
Sri Dharmasthala Manjunatheshwara
College Of ayurveda And Hospital B.M Road Thanniruhalla Hassan Karnataka – 573201
Hassan
KARNATAKA |
6360271762
ysaurabh920@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital, Hassan , Karnataka 573201 |
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 | Comparator Arm | Procedure | - | kShArasUtra, कà¥à¤·à¤¾à¤°à¤¸à¥‚तà¥à¤° | (Procedure Reference: Sushruta Samhita, Procedure details: First the participants will be kept in lithotomy position after local anaesthesia perianal region will be cleaned with antiseptic solutions followed by draping. Later gloved finger will gently be introduced into the rectum. Then a suitable selected probe will be passed through the external opening of fistula. The tip of the probe will be forwarded along the path of least resistance and will be guided by the finger in rectum to reach into the lumen of anal canal through the internal opening and i)
| | 2 | Intervention Arm | Procedure | - | kShArasUtra, कà¥à¤·à¤¾à¤°à¤¸à¥‚तà¥à¤° | (Procedure Reference: Sushruta samhita, Procedure details: First the participants will be kept in lithotomy position after local anaesthesia perianal region will be cleaned with antiseptic solutions followed by draping. Later gloved finger will gently be introduced into the rectum. Then a suitable selected probe will be passed through the external opening of fistula. The tip of the probe will be forwarded along the path of least resistance and will be guided by the finger in rectum to reach into the lumen of anal canal through the internal opening and i)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinical signs and symptoms of all types of Bhagandara
Recurrent Fistula- in-ano
Fistula- in-ano with Perineal abscess
Participants who give written surgical consent
Participants fit for surgery
Participants above the age of 18 years and below 60 years irrespective of caste, gender, religion and socio-economic status |
|
| ExclusionCriteria |
| Details |
Participants with secondary fistula due to Ulcerative colitis, Crohn’s disease, Tuberculosis, Hidradenitis Suppurativa, Carcinoma of rectum& anal canal
Participants with HIV and HBsAg positive participants
Pregnancy and lactating women
Participants with impaired cardiac, renal and hepatic function. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Unit cutting of Fistulous tract |
assessment will be done at baseline followed by weekly assessment until the fistula tract is completely healed. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| pain, discharge, granulation tissue, size of wound |
assessment will be done at baseline followed by weekly assessment until the fistula tract is completely healed. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
05/09/2023 |
| 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
|
Bhagandara is second common disease occurring in ano-rectal region after haemorrhoids. The prevalence rate of fistula-in-ano is 8.6 cases per 1 lakh population. The prevalence in men is 12.3 and in women is 5.6 cases per 1 lakh population. The male-to-female ratio is 1.8:1. The mean age of participants is 38.3 years. It is considered as one among the Mahagada in Sushruta Samhita. In Ayurveda Kshaarasutra application is well known for management of Bhagandara. Advantages of Kshaara Sutra Therapy: Simple and safe parasurgical procedure, cost-effective and ambulatory, minimal recurrence rate, no surgical complications like incontinence, stenosis and stricture. Snuhi Ksheera based Apamarga Kshaarasutra is the standard one and is proved effective treatment in the management of Fistula-in-ano. Delays in unit cutting time of the fistulous tract and difficulty of manufacturing process has limited its use. At present Apamarga Kshaarasutra is prepared by giving 11 coatings of Snuhi ksheer, 7 coatings of Snuhi and Apamarga Kshaara and 3 coatings of Snuhi and Haridra which takes a total of 21 days for preparation of the Standard Apamarga Kshaarasutra. In the current study, PROBLEMS- Collection of raw material – Collecting Snuhi Ksheer for 21 days is a problem for a practicing Doctor and its less availability. Weakening of Kshaara Sutra – As the day increases the thread used for Kshaara Sutra (tensile strength of thread) gets weak day by day hence I am trying to keep the strength of thread as stronger as possible which will reduce the changing time for participants also and benefits them in the way pain of Kshaara Sutra changing and reduces the financial load to participants. To overcome these problems, I have adopted the study of Modified Kshaara Sutra in the management of Bhagandhara SOLUTIONS As the modified Kshaara Sutra is less exposed to heat and its tensile strength is preserved it may decrease the unit cutting time. Which will be beneficial to participants in the manner of frequent pain of Kshaara Sutra changing and financially also Apamarga Kshaarasutra is prepared out of 11 coatings of Snuhi ksheer, 3 coatings of Snuhi Apamarga Kshaara and 3 coatings of Snuhi and Haridra, so a total of 21 coatings will be given.This study has been intended to evaluate whether 21 coatings in 7 days of modified Kshaara sutra is effective in comparison to standard Apamarga Kshaarasutra in terms of decreased time period of preparation and to assess the unit cutting time. |