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CTRI Number  CTRI/2021/07/034713 [Registered on: 09/07/2021] Trial Registered Prospectively
Last Modified On: 14/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical efficacy of Medicated thread prepared with Alkali of Butea monosperma and Calotropis gigantean latex in the management of Fistula-in-ano 
Scientific Title of Study   A CLINICAL EFFICACY OF PALASHA KSHARASUTRA PREPARED WITH ARKA KSHEERA IN THE MANAGEMENT OF BHAGANDARA (FISTULA-IN-ANO) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ganapathi Rao I 
Designation  Assistant Professor 
Affiliation  NKJ Ayurvedic Medical College and PG Centre 
Address  Dr Ganapathi Rao I Assistant Professor Department of Shalya Tantra, Room No: 09, YETs Sri Siddarameshwara Ayurvedic Medical College and Research Center, Naubad, Bidar
Dr Ganapathi Rao I Ph.D.Research scholar, Department of Shalya Tantra, NKJ Ayurvedic Medical College and PG Centre, Gumpa, Bidar-585403
Bidar
KARNATAKA
585402
India 
Phone  9550600886  
Fax  08482-234849  
Email  i.ganpathi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ganapathi Rao I 
Designation  Assistant Professor 
Affiliation  NKJ Ayurvedic Medical College and PG Centre 
Address  Dr Ganapathi Rao I, Assistant Professor, Department of Shalya Tantra, Room No: 09 YETs Sri Siddarameshwara Ayurvedic Medical College and Research Center, Naubad, Bidar
Dr Ganapathi Rao I, Ph.D.Research Scholer, Department of Shalya Tantra, NKJ Ayurvedic Medical College and PG Centre, Gumpa, Bidar-585403
Bidar
KARNATAKA
585402
India 
Phone  9550600886  
Fax  08482-234849  
Email  i.ganpathi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Chandrakant M Halli 
Designation  Professor and HOD 
Affiliation  NKJ Ayurvedic Medical College and PG Centre 
Address  Dr Chandrakant M Halli, Professor & HOD, Department of Shalya Tantra, NKJ Ayurvedic Medical College and PG Centre, Gumpa, Bidar
Dr Chandrakant M Halli, Professor & HOD, Department of Shalya Tantra,NKJ Ayurvedic Medical College and PG Centre, Gumpa, Bidar-585403
Bidar
KARNATAKA
585403
India 
Phone  9448222610  
Fax  08482-234849  
Email  drchalli42@gmail.com  
 
Source of Monetary or Material Support  
NKJ Ayurvedic medical College attached Hospital Sri Siddarudha Charitable Hospital, Gumpa, Bidar 
Sri Siddarameshwara Ayurvedic Medical College Hospital and Research Center, Naubad, Bidar 
 
Primary Sponsor  
Name  Dr Ganapathi RaoI 
Address  YETs Sri Siddarameshwara Ayurvedic Medical College and Research Center, Naubad, Bidar- 585402 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ganapathi rao  NKJ Ayurvedic Medical College and PG Centre, Gumpa, Bidar  Department of Shalya Tantra NKJ Ayurvedic Medical College and PG Centre, Gumpa, Bidar
Bidar
KARNATAKA 		 09550600886

i.ganpathi@gmail.com 
Dr Ganapathi rao  YETs Sri Siddarameshwara Ayurvedic Medical College and Research Center  Department of Shalya Tantra, Siddarameshwara Ayurvedic Medical College, Naubad Bidar-585402
Bidar
KARNATAKA 		 9550600886

i.ganpathi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
YETs Sri Siddarameshwara Ayurvedic Medical Collegenstitutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:A00-B99||Certain infectious and parasitic diseases. Ayurveda Condition: Bhagandara,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Efficacy of Apamarga Ksharasutra  Group B will be applied Apamarga Kshara sutra weekly upto 6 weeks 
Intervention  Efficacy of Palasha Ksharasutra Prepared with Arka Ksheera  Group A 50 Patients will be applied Palasha Ksharasutra prepared with Arka ksheera weekly ones upto 6 weeks 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patients of Fistula in ano irrespective sex, religion, occupation and economic status.
2.Patients with low anal fistula
3.Patients with one fistulous tract 
 
ExclusionCriteria 
Details  1.Patients with High anal fistula
2.Patients of Low Anal Fistula secondary to Ulcerative Colitis & CROHNS disease
3.Patients of Fistula in Ano associated with diseases like TB, DM, Ca Rectum, HbsAg and HIV
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Palasha Ksharasutra prepared with Arka-ksheera is effective in the management of Bhagandara (Fistula-in-Ano)   6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Palasha Ksharasutra prepared with Arka-ksheera is equally effective as Apamaarga Ksharasutra in the management of Bhagandara (Fistula-in-Ano)   6 weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   12/07/2021 
Date of Study Completion (India) 06/03/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 https://storage.googleapis.com/innctech/ejbps/article_issue/volume_10_december_issue_12/1701768199.pdf 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Bhagandara is one of the most common ailments pertaining to ano-rectal region. This disease causes discomfort and pain to patient, which creates problems in routine work. It is correlated with Fistula-in-ano and is encountered under Ashtamahagada. The importance of this disease was first realized by Acharya Sushruta (800-1000 B.C.)  thus, he describes as:

तेतुभगगुदवस्तिप्रदेशदारणाच्चभगन्दराइत्युच्यन्ते।

अपक्वा: à¤ªà¤¿à¤¡à¤•à¤¾:, à¤ªà¤•à¥à¤µà¤¾à¤¸à¥à¤¤à¥à¤­à¤—न्दरा: à¥¥ (सु.नि.४/४)

The litral meaning of Bhagandara is Darana , which means splitting up or bursting up.. It clearly indicates that bursting of pakwa pidaka either results into communicating track between Bhaga,Guda & Vasti pradesha with surrounding(perianal) structures.

As the wound is in anal region which is more prone to infection, thus takes long time to heal and the condition remains troublesome. Modern operative procedures often lead to complications like recurrences and incontinence.

 To alleviate such problems in the management of this disease, it was thought to find out alternative technique to treat these cases without operative complications.

Keeping in view of these complications,Acharyra Sushruta mentioned ksharasutra application in the management of bhagandara. As ksharasutra has both cutting and healing properties. Acharya Susrutha in sutrasthana ksharapaka vidhi adyaya 11th chapter mentioned various kshariaya drugs, in which Palasha and Arka are among them selected for the present study.

अथानेनैवविधनेनकुटजपलाशाश्वकर्णपारिभद्रकबिभीतकारग्वध…………….

                                                            ………… à¤¸à¤®à¥‚लफलपत्रशाखादहेत्॥(सु.सु.११/१२)

To assess the relative efficacy of Palasha ksharasutra prepared with arka ksheera in the management of Bhagandara is proposed for the present study.

 

a.     Inclusive Criteria

1.)   Patients of Bhagandara age between 16-70 years, irrespective sex, religion, occupation, economic status.

2.)   Patients with low anal fistula.

3.)   Patients with one fistulous tract.

b.     Exclusive Criteria

1.)   Patients with high anal fistula.

2.)   Patients below the age of 16 years.

3.)   Patients of Bhagandara associated with diseases like Tuberculosis, Diabetic mellitus, Ca Rectum, HBsAg, HIV will be excluded from the study, after thorough history and clinical information.

4.)   Patients of low anal fistula secondary to the ulcerative colitis and Crohn’s diseases.

 

iii. Operational Definitions / Techniques employed

Being a clinical study, 100 patients will be selected by Simple Randomized Sampling procedure. All the patients will be screened out by inclusive and exclusive criteria and registered for clinical trial in specially prepared research case sheet and divided in two equal groups.

Group 1 (Trial Group): 

50 patients of Bhagandara will be treated with Palasha Ksharasutra prepared with arka ksheera.

Group 2 (Control Group):

50 patients of Bhagandara will be treated with Standard Ksharasutra.

Materials required: -

Sterile Gloves, Gauze piece, Cotton swab, 2% lignocaine gelly, Probe, Proctoscope, 2-0 no. Barbour’s surgical linen thread, Ksharasutra, Cabinet, U.V.light, Apamarga kshara, Palasha kshara.

Procedure:

The trial PalashaKsharasutras are prepared with the help of Barbour’s surgical Lenin thread no.20, which will be smeared for 11 coatings of fresh Arka ksheera, 7 coatings of Arka ksheera and Palashakshara and 3 coatings of Arka ksheera and Haridra churna by standard Ksharasutra procedure.

Duration and follow up of the Study:

 In both the groups Ksharsutra will be replaced weekly. The total duration of the study will be 6 weeks.

                      Patients will be called on every week and the cutting rate will be assesed and recorded in a specially prepared case sheet. Observations will be analyzed on the basis of assessment parameter (both subjective and objective) clinically and scientifically before treatment and after treatment on the 1st,2 ,3 ,4 ,5 and 6th week. Finally the results will be statistically evaluated with the help of paired‘t’ test within the group for its significance.

Follow up of each patient will be made for a period of 6 months after treatment with an interval of every month.

 

 

BT G1 vs AT G1

will be assessed

AT G1 vs AT G2

will be compared

BT G2 vs AT G2

 

 

 


 
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