| CTRI Number |
CTRI/2025/04/084024 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
29/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate the efficacy of Kadali ksharsutra along with guggulu panchapal churn in the management of Bhagandara w.s.r.to Fistula in ano |
|
Scientific Title of Study
|
RANDOMIZED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY
OF KADALI KSHARSUTRA ALONG WITH GUGGULU PANCHPAL CHURN IN THE MANAGEMENT OF BHAGANDAR 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 Jaydeep Sunil Borse |
| Designation |
PG Scholar |
| Affiliation |
Matoshri Asarabai Darade Ayurved Mahavidyalaya Tal.Yeola Dist. Nashik |
| Address |
Matoshri Asarabai Darade Ayurved Mahavidyalaya And Ayurved Hospital,Department of Shalyatantra,Babhulgaon, Tal- Yeola Dist- Nashik
Nashik
MAHARASHTRA
423401
India |
| Phone |
8806729770 |
| Fax |
|
| Email |
jayborse94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj L Sonaje |
| Designation |
Professor And Head of Department Shalyatantra |
| Affiliation |
Matoshri Asarabai Darade Ayurved Mahavidyalaya Babhulgaon Tal.Yeola Dist. Nashik |
| Address |
Matoshri Asarabai Darade Ayurved Mahavidyalaya And Ayurved Hospital,Department of Shalyatantra,Babhulgaon, Tal- Yeola Dist- Nashik
Nashik
MAHARASHTRA
423401
India |
| Phone |
9404577542 |
| Fax |
|
| Email |
manojsonaje@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manoj L Sonaje |
| Designation |
Professor And Head of Department Shalyatantra |
| Affiliation |
Matoshri Asarabai Darade Ayurved Mahavidyalaya Babhulgaon Tal.Yeola Dist. Nashik |
| Address |
Matoshri Asarabai Darade Ayurved Mahavidyalaya And Ayurved Hospital,Department of Shalyatantra,Babhulgaon, Tal- Yeola Dist- Nashik
Nashik
MAHARASHTRA
423401
India |
| Phone |
9404577542 |
| Fax |
|
| Email |
manojsonaje@gmail.com |
|
|
Source of Monetary or Material Support
|
| Matoshri Asarabai Darade Ayurved Mahavidyalaya And hospital Babhulgaon , Tal - yeola, Dist - nashik 423401 |
|
|
Primary Sponsor
|
| Name |
Matoshri Asarbai Darade Ayurved Mahavidyalaya |
| Address |
Matoshri Asarabai Darade Ayurved Mahavidyalaya And hospital Babhulgaon , Tal - yeola, Dist - nashik 423401 |
| Type of Sponsor |
Other [Research institution and hospital] |
|
|
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 Jaydeep Sunil Borse |
Matoshri Asarabai Darade Ayurved Mahavidyalaya And Ayurved Hospital Babhulgaon |
OPD No.2, shalyatantra department, matoshri asarabai darade ayurved college and hospital, babhulgaon, tal. yeola dist. nashik
Nashik
MAHARASHTRA |
8806729770
jayborse94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,Matoshri Ayurved Mahavidyalaya |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K605||Anorectal fistula. Ayurveda Condition: BAGANDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | kShArasUtra, क्षारसूत्र Pradhan Karma | (Procedure Reference: Chakradatta Tika,Dr.Indradeva Tripathi,Nadivrana chikitsa 12-13,Choukhamba Sanskrit Sansthan, 2015,Page no.268, Procedure details: 1. Prepared patient will be taken on operation table.
2. Suitable anaesthesia will be given.
3. The patient will be given lithotomy position.
4. The peri-anal area will thoroughly clean with antiseptic lotions and draped well with the help of sterile drapes.
5. Then the gloved finger of left hand of surgeon smeared with lubricant for a fistula on the left side of the patient will be gently inserted into the rectum. Then a suitably selected probe, generally curved one will be introduced through the external opening of the fistula till the point it touched the tip of the intra rectal finger and brought out of the anal verge.
Partial Fistulectomy will be done.
6. The eye of the probe will be threaded with the help of surgical linen no.20(Ksharsutra). Then the probe will be withdrawn thus leaving behind the thread throughout the entire course of fistulous track. The two ends of thread will be tied outside the anal canal. Similar procedure will be carried out with right hand for fistula with external opening on right side of the patient.
)
(1) Medicine Name: Guggulu Panchpal Churn, Reference: Ashtanghriday Uttarsthana 28/40, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Duration: 1 Months | | 2 | Comparator Arm | Procedure | - | kShArasUtra, क्षारसूत्र | (Procedure Reference: 4. Chakradatta Tika,Dr.Indradeva Tripathi,Nadivrana chikitsa 12-13,Choukhamba Sanskrit Sansthan,2015.page no.268 , Procedure details: 1. Prepared patient will be taken on operation table.
2. Suitable anaesthesia will be given.
3. The patient will be given lithotomy position.
4. The peri-anal area will thoroughly clean with antiseptic lotions & draped well with the help of sterile drapes.
5. Then the gloved finger of left hand of surgeon smeared with lubricant for a fistula on the left side of the patient will be gently inserted into the rectum. Then a suitably selected probe, generally curved one will be introduced through the external opening of the fistula till the point it touched the tip of the intra rectal finger and brought out of the anal verge.
Partial Fistulectomy will be done.
6. The eye of the probe will be threaded with the help of surgical linen no.20(Ksharsutra). Then the probe will be withdrawn thus leaving behind the thread throughout the entire course of fistulous track. The two ends of thread will be tied outside the anal canal. Similar procedure will be carried out with right hand for fistula with external opening on right side of the patient.
)
(1) Medicine Name: Guggulu Panchapal Churn, Reference: Sahastrayog , Dr. Ramnivas Sharma,Dr. Surendra Sharma,Chaukhamba Sanskrit Pratishthan,2007.page no. 139 , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Duration: 1 Months |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient with all Classical sign and symptoms of Fistula In Ano.
2) Patient with age group 18 years to 60 years.
3) Patient suffering from fistula in ano specially of low level with simple and complex fistulae will be taken.
4) Patient with HB more than 8 gm %
5) Patient will be selected irrespective of Gender, Religion, Socio-economic status, length of tract , Severity of Disease and Chronicity |
|
| ExclusionCriteria |
| Details |
Pregnancy
2) Patient with HB less than 8 gm %
3) Multiple fistulae in ano , High Anal fistula.
4) Systemic diseases like Extrapulmonary Tuberculosis, Malignancy, Ulcerative colitis, HIV, HBsAG, VDRL positive patient.
5) Patient suffering from uncontrolled DM.
6) Fistula developing along with Piles with Fissure, Prolapsed Rectum, Crohn’s Disease, Rectal polyp, Perianal abscess, etc. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
the Parametres will be noted down before and after treatment.The patient will be diagnosed based on symptoms of parikartika. Explained in ayurvedic And modern texts.
1.Pain
2.Healing
3.local tenderness
4.wound healing
5.discharge
6.length of track
7.unit cutting time |
1st,2nd,3rd,4th,5th,6th,7th,8th,9th,10th,11th,12th weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
09/04/2025 |
| 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
|
Present trend in the treatment of fistula in ano in modern medicine is the wide excision of the tract along with the adjacent tissues and wound is allowed to heal, many other surgical procedures example Fistulotomy ,Fistulectomy ,Seton techniques , Flap procedure ,LIFT procedure ,LASER , Endoscopic ablation , Fibrin glue , Bioprosthetic plug were tried out but none could be adopted as a perfect and curative technique by most of the surgeons, usually inspite of best efforts on the part of the surgeon “the patient after some time again reports pus discharge from the same scar” the frequency of the recurrence is very high and anal continence can also be found in patients . In spite of much advances in modern medical and surgical science, it is reported that it is not possible to prevent chances of post operative complications like its recurrence rate, high risk of impared continence and nonhealing of the wound after surgical treatment. In additions to this there will be severe post operative pain which persist for many days morever surgical treatment requires hospitalization, regular dressing and post op care for longer duration, to overcome such problems, surgical field is planning for some alternative technique to treat these cases with minimal operative complications, recurrence and failure.
For proper healing of wound drug should have two properties as follows: 1] Vrana Shodhan: for cleaning of the wound 2] Vrana Ropan: for healing of the wound It is important to find simple composition which have both vrana shodhan and vrana ropan, Vednahar properties. Ayurvedic line of treatment for bhagandara includes medical, para surgical and surgical management. Parasurgical management includes ksharakarma, agnikarma and varti ksharsutra treatment in bhagandara is chemical fistulectomy rather than surgical fistulectomy. In sushrut Samhita ksharsutra procedure has been described as the best remedy for the disease of nadivrana. there are many ksharsutra which can be used in bhagandar eg guggul coated ksharsutra ,snuhikshir ksharsutra etc. Sushruta in Kshar Paka Vidhi Adhyaya has mentioned 23 drugs from which Kshar can be prepared.Among which Kadali is one of the drug. Kadali has Madhur Rasa, Guru and Snigdha guna , Sheeta Veerya , Madhur Vipaka and Pitta Vatahar properties . It is easily Available . Cost Effective. |