| CTRI Number |
CTRI/2024/08/073025 [Registered on: 28/08/2024] Trial Registered Prospectively |
| Last Modified On: |
26/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ksharasutra in Bhagandhara(Fistula in Ano) |
|
Scientific Title of Study
|
AN OPEN LABELLED CLINICAL STUDY TO EVALUATE THE EFFECT OF ERANDA KARKATI
KSHEERA PAPAYA LATEX BASED CHITRAKA KSHARASUTRA IN THE MANAGEMENT OF
BHAGANDARA W.S.R TO 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 Adarsh Shahapurkar |
| Designation |
PG Scholar |
| Affiliation |
SDM College of Ayurveda Kuthpady Udupi |
| Address |
Department of PG studies in Shalya tantra SDM College of Ayurveda Hospital and Research centre Kuthpady Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
8105701995 |
| Fax |
|
| Email |
adarshms120@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajneesh V Giri |
| Designation |
HOD and Professor |
| Affiliation |
SDM College of Ayurveda Kuthpady Udupi |
| Address |
Department of Shalya tantra SDM College of Ayurveda Hospital and Research centre Kuthpady Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9845407543 |
| Fax |
|
| Email |
drrajneeshgiri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajneesh V Giri |
| Designation |
HOD and Professor |
| Affiliation |
SDM College of Ayurveda Kuthpady Udupi |
| Address |
Department of Shalya tantra SDM College of Ayurveda Hospital and Research centre Kuthpady Udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9845407543 |
| Fax |
|
| Email |
drrajneeshgiri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalya tantra SDM College of Ayurveda Hospital and Research centre Kuthpady Udupi Karnataka 574118 India |
|
|
Primary Sponsor
|
| Name |
SDM College of Ayurveda |
| Address |
SDM College of Ayurveda Kuthpady Udupi 574118 |
| 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 Adarsh Manohar Shahapurkar |
Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital |
Opd 5 and Operation Theatre department of shalyatantra, Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital Kuthpady Udupi 574118
Udupi
KARNATAKA |
8105701995
adarshms120@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital Udupi |
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 | - | kShArasUtra, कà¥à¤·à¤¾à¤°à¤¸à¥‚तà¥à¤° | (Procedure Reference: Chakradatta, Procedure details: The technique of preparation of Ksharasutra is the same as Standard Snuhi-Apamarga Ksharasutra by the Department of Shalya, Shalakya, IMS, Banaras Hindu University, Varanasi.
It is prepared by 21 coatings in which 11 coatings are of Eranda Karkati Ksheera, 7 coatings of Eranda Karkati Ksheera and Chitraka Kshara and 3 coatings of Eranda Karkati Ksheera and Haridra Churna.
Pre-operative procedure:
1)
2) 3) 4) 5) 6)
Afterhistorytaking,performingtheexaminations,andinvestigations,theprocedurewillbeexplainedto the patient, and consent will be taken.
NBM6hoursbeforesurgery
Perianal Part preparation will be done
INJ T.T 0.5ml IM
INJ XYLOCAINE 0.2cc SC (Test Dose)
Soap water Enema will be given before 2 hours to the procedure.
Operative procedure-
The patient will be comfortably laid in the lithotomy position. Local anesthesia in required dosage
will be injected into the sphincters around the anus. Dilatation with lubricated gloved fingers will be done and findings reconfirmed. A malleable copper probe will be introduced into the external opening and it will be carefully introduced along the track. The finger kept in the anal canal will support the movement of the probe towards the internal opening. The probe will be brought out of the internal opening and then it will be carefully taken out through the anal canal. A Barbour’s thread of suitable length will be passed through the eye of the probe and the probe will be pulled out to position the thread in the track. The two ends of the thread will be tied outside the anal orifice. Surgical pad will be applied to the area. T bandage will be done, and the patient will be shifted to the post-operative ward.
9
Post operative measures-
Internal Medications
1. T. Triphala Guggulu450mg 1-1-1 (After food)
2. T. Gandhaka Rasayana (250mg) 1-1-1 (After food)
3. Avipattikara Choorna-5g HS with warm water
External Medications
1. Sitz Bath with lukewarm water added with10 ml Dettol, twice daily
2. Jathyadi taila 10 ml infusion Per rectum at Bed time
A special proforma will be prepared and the efficacy of the Ksharasutra will be assessed based on
the subjective and objective parameters.)
(1) Medicine Name: Chitraka , Reference: Susruta samhita sutrasthan11 adhyaya , Route: Rectal, Dosage Form: Kshara, Dose: 00(NA), Frequency: sos, Duration: 1 Weeks(2) Medicine Name: Papaya, Reference: Other than classical , Route: Rectal, Dosage Form: Not Applicable, Dose: 00(NA), Frequency: sos, Duration: 1 Weeks |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with clinical signs and symptoms of Bhagandara or Fistula in ano as explained in
Ayurvedic and modern text books |
|
| ExclusionCriteria |
| Details |
Patients suffering from systemic diseases like uncontrolled diabetes, Chronic Renal, Hepatic,
Cardiac disorders
Patients suffering from secondary fistula due to carcinoma, ulcerative colitis, Tuberculosis
Patients suffering from infectious disease like H.I.V, Hepatitis-B.
High anal fistula
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out Unit Cutting time of Chitraka Ksharasutra by changing the ksharasutra every weekly until the tract gets completely cut through and until wound heals |
St Mark Anal incontinence score
Discharge in Perianal region
Itching in Perianal region |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Observing UCT of fistulous track,
Anal incontinence
|
Weekly until track heals upto 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
07/09/2024 |
| 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
|
The Indian Council of Medical Research (ICMR) conducted randomized multi-centric clinical trials on Ksharasuthra therapy and found that, the recurrence of anal fistula was only 4% as compared to 11% in patients who had undergone conventional surgery [7] According to Classics, Snuhi Ksheera is used in the preparation of Ksharasutra. But Snuhi is not available throughout the year, the time for collection is in Adana Kala particularly in Shishira Ritu, Snuhi coagulates within few minutes of collection, hence in order to overcome these lacuna Eranda Karkati Ksheera (Papaya latex) is used, as it easily available, has binding properties and can be preserved for long duration [8] . After the establishment of Ksharasutra as an effective treatment methodology, it has been a constant endeavour of Ayurvedic surgeons to bring in innovative and effective changes in the preparation of Ksharasutra. This work of preparation of Eranda Karkati Ksheera (Papaya latex) based Chitraka Ksharasutra is also a step in the same direction |