| CTRI Number |
CTRI/2025/02/080012 [Registered on: 06/02/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To know the effect of vrisha ksharasutra in the management of fistula in ano. |
|
Scientific Title of Study
|
A Randomized controlled clinical study to evaluate the efficacy of vrisha ksharasutra with apamarga ksharasutra in the patients 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 |
DrAnakarla Harish Kumar |
| Designation |
Post Graduate Scholar |
| Affiliation |
S.V. Ayurvedic College and Hospital |
| Address |
Department of Shalya Tantra, S.V.Ayurvedic College and Hospital,Tirupati.
Chittoor
ANDHRA PRADESH
517501
India |
| Phone |
9505325914 |
| Fax |
|
| Email |
Harish99080@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrTSrinivasa Rao |
| Designation |
Associate Professor |
| Affiliation |
S.V.Ayurvedic College |
| Address |
Department of Shalya Tantra, S.V.Ayurvedic College and Hospital,Tirupati.
Chittoor
ANDHRA PRADESH
517501
India |
| Phone |
9440601161 |
| Fax |
|
| Email |
dr.srinivasayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrTSrinivasa Rao |
| Designation |
Associate Professor |
| Affiliation |
S.V.Ayurvedic College |
| Address |
Department of Shalya Tantra, S.V.Ayurvedic College and Hospital,Tirupati.
Chittoor
ANDHRA PRADESH
517501
India |
| Phone |
9440601161 |
| Fax |
|
| Email |
dr.srinivasayu@gmail.com |
|
|
Source of Monetary or Material Support
|
| S.V.Ayurvedic College and Hospital,Tirupati,Chittoor,Andhra pradesh,India.-517501. |
|
|
Primary Sponsor
|
| Name |
S.V.Ayurvedic College and Hospital |
| Address |
Near SVIMS campus,Tirupati,Chittor,Andhra Pradesh,pin 517501 |
| 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 |
| DrAHarish kumar |
S.V.Ayurvedic College and Hospital. |
Department of shalya tantra, op.5, near svims campus, tirupati,chittoor andhra pradesh.
Chittoor
ANDHRA PRADESH |
9505325914
Harish99080@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of TTDs S.V. Ayurvedic College |
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 | Comparator Arm | Procedure | - | kShArasUtra, कà¥à¤·à¤¾à¤°à¤¸à¥‚तà¥à¤° | (Procedure Reference: Sushrutha Samhitha S.S,Su 25/3,S.S.Ci 8/6,Charaka samhitha ,C.S.Ci 12/97., Procedure details: ksharasutra application)
| | 2 | Intervention Arm | Procedure | - | kShArasUtra, कà¥à¤·à¤¾à¤°à¤¸à¥‚तà¥à¤° | (Procedure Reference: Sus.Su.25/3, Sus.Chi.8/6, Procedure details: 1.Under aseptic conditions, anal dilatation is done
2. local anaesthesia is given with 2% Xylocaine Solution
3. the probe was introduced through the external opening & taken out through the internal opening.
4. after that Vrisha Kshara sutra application is done , knots are secured.
5.T-bandage is applied.)
(1) Medicine Name: Abhayarista, Reference: Bhaishajya ratnavali arsho rogadhikara 9/175-180, Route: Oral, Dosage Form: Arishta, Dose: 15(ml), Frequency: tds, Duration: 2 Months(2) Medicine Name: Panchasakara churnam, Reference: Ayurveda sara sangraha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: hs, Duration: 2 Months(3) Medicine Name: Sapta vimshati guggulu, Reference: Bhaishajya ratnavali Bhagandara chikitsa, Route: Oral, Dosage Form: Guggulu, Dose: 1000(mg), Frequency: bd, Duration: 2 Months |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients irrespective of Gender and religion from the age group of 20 to 60 years.
2. Patients Patients with signs and
symptoms of Bhagandhara.
3. Patients who are
diagnosed as Fistula-in-ano. |
|
| ExclusionCriteria |
| Details |
1. Concomitant Ano-rectal conditions like
ulcerative colitis, malignancy, Crohn’s
disease, multiple fistulae.
2. Pregnancy.
3. Tuberculosis.
4. Obstructive Uropathies.
5.Systemic diseases like CAD, Portal hypertension.
6.Patients with uncontrolled blood sugars |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Accessing unit
cutting time and tenderness for every week until
cut open of a track. The efficacy is calculated by
comparing the both subjecive and objective
parameters of both ksharasutras each other. |
Accessing the pain, discharge, itching, unit
cutting time and tenderness for every one week until
cut open of a track. The efficacy is calculated by
comparing the both subjecive and objective
parameters of both ksharasutras each other. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Complete healing time, reoccurrences & any
other complications like incontinency, discharge,
etc. |
After the entire track is cut open, follow up with
a patient for 2 months with an interval of 15
days. |
|
|
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)
|
09/02/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 Bhagandara has been explained in all Brihatrayee and laghutrayee’s. But specially Acharya Sushruta has given a very detailed description about the etiopathogenesis, classification (S.S.Ni.4) complication, management and other aspects of Bhagandara. AcharyaSushruta has described surgical approach like excision of fistulous track in detail (S.S.Su 25/3, S.S. Ci 8/6) but also felt the necessity of para-surgical approach like Kshara Sutra (S.S.Ci 17/32, C.S.Ci 12/97. Chakradatta –Arshavyadhi adhikara). Since he was not satisfied with only surgical excision in specific patients who are emaciated, weak and frightful, he then advised Kshara Sutra. He also explained method of preparation of kshara sutra. In the present research is to study the efficacy of Vrisha Kshara Sutra is the best treatment opinion for the management of Bhagandara is taken from reference of Sushruta Samhita (Su.Su.). Hence the process of Vrisha Kshara preparation is done as mentioned in the Sushruta Samhita sutra sthana 11th chapter.The ingredients of Vrisha ksharasutra consists of Vrisha kshara, snuhi kshira, haridra churnam. Acharya Sushruta in sutrasthana Ksharapaka vidhi adhayaya has mentioned 21drugs can be used for the preparation of Kshara among which Vrisha is selected in the preparation of Kshara Sutra as the kshara has properties, Chedana, Bhedana, Lekhana, anti-bacterial, anti-microbial, anti-inflammatory, anti-spasmodic, anti hemorrhagic, anti-helminthic.
Lacunas, If any: Kshara sutra is well known treatment procedure accepted and also in practice since ages. But the standard Apamarga Kshara Sutra is causing pain during its stay in tract and its availability in particular season. To overcome this situation, the present study is selected. Need for the study: To lead the patient to get relief from this painful condition and to improve the quality of life by adopting a para surgical procedure which is free from surgical complications and recurrences. Scope of the study: . Plant is ready for use in all seasons ,easy for the preparation of Ksharasutra in batches instantly when required. |