| CTRI Number |
CTRI/2025/04/084054 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
26/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study two ksharasutra, kutaja ksharasutra and apamarga ksharasutra in patient with bhagandra ( fistula-in-ano) |
|
Scientific Title of Study
|
A Comparative Clinical Study On The Effect Of Kutaja Kshara Sutra And Apamarga Kshara Sutra 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 Pooja B D |
| Designation |
Pg Scholar- Department of Shalya Tantra |
| Affiliation |
Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital Hassan |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM road-Thanniruhalla Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9686934295 |
| Fax |
|
| Email |
pooja10aaglecha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gopikrishna B J |
| Designation |
Professor - Department of Shalya Tantra |
| Affiliation |
Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital Hassan |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM road-Thanniruhalla Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9886360901 |
| Fax |
|
| Email |
drgopiboyapati@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gopikrishna B J |
| Designation |
Professor - Department of Shalya Tantra |
| Affiliation |
Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital Hassan |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM road-Thanniruhalla Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9886360901 |
| Fax |
|
| Email |
drgopiboyapati@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM road-Thanniruhalla Hassan, Karnataka, India, 573201 |
|
|
Primary Sponsor
|
| Name |
Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital Hassan |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM road-Thanniruhalla Hassan, Karnataka, India, 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 Pooja B D |
Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital Hassan |
opd number 11
Department of shalya tantra
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM road-Thanniruhalla Hassan
Hassan
KARNATAKA |
9686934295
pooja10aaglecha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan |
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, क्षारसूत्र | (Procedure Reference: Sushrutha Samhita, Procedure details: ● First the participant will be made to lie down in a lithotomy position after giving local (Inj Lignocaine) anesthesia.
● Operating site will be cleaned with antiseptic solutions (Betadine 10%) & draped. Later gloved finger will gently be introduced into the rectum. Then a suitable selected probe will be passed through the external opening of the fistula.
● The tip of the probe will be forwarded along the path of least resistance & will be guided by the finger in rectum to reach into the lumen of anal canal through the internal opening & its tip will be finally directed to come out of anal orifice. Then a suitable length of Apamarga Kshara Sutra will be taken & threaded into the eye of the probe.
● There after the probe will be pulled out through the anal orifice,to leave the thread behind in the fistulous tract. The two ends of the thread will be then tied together with a moderate tightness outside the anal canal.
)
| | 2 | Intervention Arm | Procedure | - | kShArasUtra, क्षारसूत्र | (Procedure Reference: Sushrutha Samhita, Procedure details: ● First the participant will be made to lie down in a lithotomy position after giving local (Inj Lignocaine) anesthesia.
● Operating site will be cleaned with antiseptic solutions (Betadine 10%) & draped. Later gloved finger will gently be introduced into the rectum. Then a suitable selected probe will be passed through the external opening of the fistula.
● The tip of the probe will be forwarded along the path of least resistance & will be guided by the finger in rectum to reach into the lumen of anal canal through the internal opening & its tip will be finally directed to come out of anal orifice. Then a suitable length of Kutaja Kshara Sutra will be taken & threaded into the eye of the probe.
● There after the probe will be pulled out through the anal orifice,to leave the thread behind in the fistulous tract. The two ends of the thread will be then tied together with a moderate tightness outside the anal canal.
)
|
|
|
|
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
Fistula- in-ano with Perianal abscess
Participants who give written surgical consent
Participants fit for surgery
Participants above the age of 18 years and below 60years irrespective of caste,gender, religion and socio-economic status.
|
|
| ExclusionCriteria |
| Details |
Participants with secondary f istula due to Ulcerative colitis, Crohns disease,Tuberculosis, Hidradenitis Suppurativa, Carcinoma of rectum& anal canal ,condyloma acuminata,condyloma lata
Participants with HBsAg and retro 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 time of fistulous track |
assessment will be done at baseline, followed by weekly assessment until the fistula tract is completely healed |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
pain
discharge
healing of wound |
will be assessed 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
|
N/A |
|
Date of First Enrollment (India)
|
18/04/2025 |
| 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="1"
Months="2"
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 the second common disease occurring in ano-rectal region
after Arshas. The prevalence rate of fistula-in-ano is8.6 cases per1lakh population.Estimates
suggest that it affects approximately 0.05% to 0.1%
of the general population in India. The prevalence in men is 12.3 cases
per 1 lakh population 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
Kshara Sutra application is well known in the management of Bhagandara. Advantages
of KsharaSutra Therapy: Simple and safe
parasurgical procedure,cost-effective and ambulatory, minimal recurrence rate,
no surgical complications like incontinence, stenosis and stricture..
At
present Apamarga Ksharasutra is prepared by giving 11coatings of SnuhiKsheera,7
coatings of Snuhi and Apamarga Kshara and 3 coatings ofSnuhiandHaridrawhichtakesatotalof21daysfor
preparation of the Apamarga Kshara Sutra.
Acharya
Susruta ,while describing the process of Kshara extraction in sutrasthana chapter-11
has mentioned 23 drugs and Kutaja is first and foremost drug. Acharya Sushruta
in the 17th chapter of SushrutaChikitsaSthanahasadvocatedtheKsharaSutraanditsapplication.Chakrapanidattahas
described the preparation of Kshara Sutra by smearing the latex of Snuhi,
Kshara and Haridra repeatedly.
In
the current study the potential synergistic effect of comparing Apamarga Kshara
Sutra, known for its healing qualities of the fistulous tract but its demerits
such as irritation and burning sensation during primary and successive changes
and also local skin irritation occurs during course of therapy and it is only Kaphahara to overcome these with Kutaja Kshara Sutra, where Kutaja possesses qualities like Kaphapitta Doshahara and has Sheeta Virya, which merit further study
to assess the potential of Kutaja Kshara
Sutra against the demerits of Apamarga
Kshara Sutra. |