| CTRI Number |
CTRI/2025/05/086913 [Registered on: 14/05/2025] Trial Registered Prospectively |
| Last Modified On: |
13/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Study Effect Of Navakarshika Guggulu With Apamarga Ksharsutra In Bhagandara |
|
Scientific Title of Study
|
An Open Randomized Controlled Clinical Study To Evaluate The Add On
Effect Of Oral Administration Of Navakarshika Guggulu Along With
Apamarga Ksharsutra In The Management Of Bhagandara W.S.R To Low Anal Fistula.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Maitri Pareshkumar Bhavsar |
| Designation |
MS Scholar Shalya Tantra |
| Affiliation |
R A Podar Ayurvedic Medical College ,Worli. |
| Address |
Dept Of Shalyatantra
R A Podar Ayurvedic Medical College ,Worli,Mumbai, Maharashtra-400018
India
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9723308290 |
| Fax |
|
| Email |
maitribhavsar18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradnya Rajesh Kapse |
| Designation |
Assistant Professor |
| Affiliation |
R A Podar Ayurvedic Medical College ,Worli. |
| Address |
Dept Of Shalyatantra
R A Podar Ayurvedic Medical College ,Worli,Mumbai, Maharashtra-400018
India
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9723308290 |
| Fax |
|
| Email |
rasrajk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradnya Rajesh Kapse |
| Designation |
Assistant Professor |
| Affiliation |
R A Podar Ayurvedic Medical College ,Worli. |
| Address |
Dept Of Shalyatantra
R A Podar Ayurvedic Medical College ,Worli,Mumbai, Maharashtra-400018
India
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9723308290 |
| Fax |
|
| Email |
rasrajk@gmail.com |
|
|
Source of Monetary or Material Support
|
| R A Podar Ayurvedic Medical College ,Worli,Mumbai,Maharashtra,India -400018 |
|
|
Primary Sponsor
|
| Name |
R A Podar Ayurvedic Medical College ,Worli |
| Address |
Dept Of Shalyatantra,R A Podar Ayurvedic Medical College ,Worli,Mumbai,Maharashtra,India-400018 |
| Type of Sponsor |
Government 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 Maitri Bhavsar |
M A Podar Hospital |
OPD NO 10,Shalyatantra Department ,Dr Annie Besant Road,Worli,Mumbai,Maharashtra,India-400018
Mumbai
MAHARASHTRA |
9723308290
maitribhavsar18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC R A Podar ayurvedic medical college,Worli |
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 | Drug | Classical | | (1) Medicine Name: Navakarshika Guggulu, Reference: - योगरत्नाकर २७/९ , Route: Oral, Dosage Form: Guggulu , Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: -Udaka), Additional Information: - | | 2 | Comparator Arm | Procedure | - | kShArasUtra, क्षारसूत्र | (Procedure Reference: चक्रदत्त अशॉ रोग अधिकार-148, Procedure details: Procedure Done once a Week For 8 weeks or Until Fistula Tract Cut Through Occur.)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with low anal fistula.
2.Irrespective of sex, religion, occupation, economic status and education status.
3.Patients within the age of 20-60yrs.
|
|
| ExclusionCriteria |
| Details |
1.Patient with high anal fistula.
2.Patients with complex anal fistula.
3.Patient with recurrent fistula.
4.Patient suffering from HIV, HbsAG , any other immunosuppressant Disorders and malignancy will be excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cutting rate of fistula track will be enhanced with oral administration of navakarshika guggulu |
8 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparatively healing of fistula tract will be faster with oral administration of navakarshika guggulu |
8 Weeks |
| There will be significant reduction in pain |
8 Weeks |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/05/2025 |
| 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 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
|
OBJECTIVE:-
PRIMARY OBJECTIVE –
To evaluate the shodhana property of navakarshika guggulu.
SECONDARY OBJECTIVE –
1 To evaluate the ropana
property of navakarshika guggulu.
2 To evaluate the analgesic property
of navakarshika
guggulu.
Approximately 39 subjects per group should
be recruited for the trial.
Group A Navakarshika guggulu orally for 4
weeks along with Apamarga ksharsutra= 39
Group B Apamarga ksharsutra = 39
SELECTION OF PATIENT :-
Selection will be
made on chief complaints of patient, past history, history of associated
disease, inspection,
palpation, digital examination, proctoscopy an
required criteria as per specially designed Performa fulfilling the
inclusion criteria is taken for the study.
ASSESSMENT OF SYMPTOMS :-
Patient will be assess weekly for 8
weeks. During each visit UCT will be measure and patient will be questioned
regarding the clinical features mentioned in assessment criteria. If fistula
tract cut through occur before 8 weeks, then further procedures will be done.
FOLLOW UP:-
Patient will come for weekly follow up
for 8 weeeks.
ASSESSMENT CRITERIA :-
The study will be strictly based on
the assessment of objective parameters and subjective parameters by grading
them.
The data obtained will be analyzed
statistically.
OBJECTIVE PARAMETER :-
1.
Unit cutting time –
UCT
is derived by following formula = Total no. of
days for cutting
Initial length of track in cm
2.
Srava –
No
Discharge – 0
Mild
(if wound wets 1×1 cm gauze piece) in 24 hour – 1
Moderate
(if wound wets 1×1 cm 2 gauze piece) in 24 hour – 2
Severe
(if wound wets more than 2 gauze piece)
in 24 hour -3
SUBJECTIVE PARAMETER :-
1.
Pain – pain measure by VAS Scale
CONCLUSION :- The result will be recorded
before and after treatment and conclusion will be drawn on the basis of
statistical analysis.
END POINT:-
1.Cutting rate of fistula track will be
enhanced with oral administration of navakarshika guggulu.
2.Comparatively healing of fistula
tract will be faster with oral
administration of navakarshika guggulu.
3.There will be significant reduction
in pain. |