| CTRI Number |
CTRI/2026/02/103846 [Registered on: 13/02/2026] Trial Registered Prospectively |
| Last Modified On: |
12/02/2026 |
| 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
|
To Study the add on effect of hanspadyadi tail pooran with Apamarga Ksharsutra in the management of Bhagandara |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Trial to Evaluate the An Add-on Effect of Hanspadyadi Tail Pooran with Apamarga Ksharasutra in the Management
of Bhagandara |
| 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 Aniket Suresh Shrungarputle |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College Of Ayurved and Research Centre |
| Address |
PDEAs College of Ayurved and Research centre Third Floor Shalayantra Department Sector no 25 Pradhikaran Nigdi,PUNE Maharashtra 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
8329135743 |
| Fax |
|
| Email |
aniketsputle1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhavi Banarase |
| Designation |
Professor and H.O.D |
| Affiliation |
PDEAs College Of Ayurved and Research Centre,Nigd,Pune |
| Address |
PDEAs College of Ayurved and Research centre Third Floor Shalayantra Department Sector no 25 Pradhikaran Nigdi,PUNE
Pune
MAHARASHTRA
411044
India |
| Phone |
9881679773 |
| Fax |
|
| Email |
dr.madhavibanarase209@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhavi Banarase |
| Designation |
Professor and H.O.D |
| Affiliation |
PDEAs College Of Ayurved and Research Centre,Nigd,Pune |
| Address |
PDEAs College of Ayurved and Research centre Third Floor Shalayantra Department Sector no 25 Pradhikaran Nigdi,PUNE
Pune
MAHARASHTRA
411044
India |
| Phone |
9881679773 |
| Fax |
|
| Email |
dr.madhavibanarase209@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College Of Ayurved and Research Centre,Nigdi,Pune,Maharashtra,India, 411044 |
|
|
Primary Sponsor
|
| Name |
PDEAs College Of Ayurved and Research CentreNigdPune |
| Address |
PDEAs College of Ayurved and Research centre, Third Floor Shalayantra Department, Sector no 25, Pradhikaran Nigdi,PUNE Maharashtra 411044 |
| 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 Aniket Suresh Shrungarputle |
Ayurved Rugnalaya and Snowbell Multispeciatlity hospital, Nigdi |
Ayurved Rugnalaya and Snowbell Multispeciatlity hospital,Shalyatantra Dept
OPD No.123A pradhikaran sector No.27 Nigdi, Pune
Pune
MAHARASHTRA |
8329135743
aniketsputle1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: BAGANDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | pUraNa-karma, पूरण-कर्म | (Procedure Reference: chakradatta, Procedure details: (Procedure Reference: Chakradatta, Procedure details: Ksharsutra parivartan done under aspectic precaution puran of sterilised koshna Hanspadyadi Taila into the track. According to depth of track quantitatively sufficient tail will be infiltrate into the track with the help of syringe until the track heals then dressing will be done. Ksharsutra will be change once a week &progress will be assessed on weekly basis.))
(1) Medicine Name: Hanspadyadi Tail, Reference: chakradata, Route: Rectal, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 1 Months | | 2 | Comparator Arm | Procedure | - | kShArakarma, क्षारकर्म | (Procedure Reference: Dr PJ Deshpande, Procedure details: Under aseptic precautions, the fistula tract was irrigated with Betadine solution & cleaned thoroughly. The old Ksharsutra was removed after proper cleaning of the tract & replaced with a new Ksharsutra. The new thread was placed inside the fistula tract & secured properly to facilitate adequate drainage & promote healing.)
|
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with presenting symptoms of Bhagandara like
1. GUDSHULA
2. GUDKANDU
3. GUDSRAVA
minimum 2 out of 3 symptoms
2.Between the age group of 19-60 years.
3.Patients will be selected Irrespective of Age, Gender, cast income
group, occupation, and Prakriti |
|
| ExclusionCriteria |
| Details |
Known case of -1. Malignancy/Tuberculosis/HIV/ Uncontrolled Diabetes Mellitus
2. systemic diseases
1. Ulcerative Colitis
2. Crohn’s disease
3. Carcinoma of the Rectum |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the additional clinical benefit of Hanspadyadi Taila Poorana
as an add-on therapy with Apamarg Ksharasutra in the management of
Bhagandara for 28 days, based on parameters such as wound healing,
reduction in pain, discharge, and tract closure in individuals aged 19 to 60
years. |
Patient will be followed up on 7th, 14th, 21st, 28th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To observe and document any adverse effects or complications
associated with Hanspadyadi Taila Poorana as an add-on therapy with
Apamarg Ksharsutra in the management of Bhagandara over 28 days, if
any. |
Patient will be followed up on 7th, 14th, 21st, 28th day. |
|
|
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)
|
02/03/2026 |
| 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
|
Bhagandara (fistula-in-ano) is a chronic, infected tract in the perianal region, described in detail by Acharya Sushruta and classified as an Ashta Mahagada due to its recurrent nature. While Kshara Sutra is an effective treatment, it may cause irritation. Hanspadyadi Tail, with Vrana Shodhaka and Vrana Ropaka properties, is used in Taila Poorana to promote faster healing with fewer complications. |