| CTRI Number |
CTRI/2026/04/109439 [Registered on: 27/04/2026] Trial Registered Prospectively |
| Last Modified On: |
27/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Sphatika Drava Basti in the Management of Second-Degree Hemorrhoids. |
|
Scientific Title of Study
|
A RANDOMISED CONTROLLED CLINICAL TRIAL ON THE EFFECT OF SPHATIK DRAVA BASTI IN THE MANAGEMENT OF ARSHA WSR TO SECOND DEGREE INTERNAL HAEMORRHOIDS. |
| Trial Acronym |
WSR - with special reference |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohini Mukund Kedar |
| Designation |
PG Scholar |
| Affiliation |
Dr. G. D Pol, Foundation, YMT Ayurvedic Medical College And Hospital |
| Address |
DR G D POL FOUNDATION, YMT Ayurvedic Medical College And Hospital, 3rd Floor, surgery Department, Sector- 4, Kharghar , Navi Mumbai
Raigarh
MAHARASHTRA
DR G D POL FOUNDATION, YMT Ayurvedic Medical College And Hospital, 3rd Floor, surgery Department, Sector- 4, Kharghar , Navi Mumbai
Raigarh
MAHARASHTRA
Raigarh
MAHARASHTRA
410210
India |
| Phone |
7972928110 |
| Fax |
|
| Email |
dnyanesh7373@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr DD Chavan |
| Designation |
HOD AND ASSOCIATE PROFESSOR |
| Affiliation |
Dr. G. D Pol, Foundation, YMT Ayurvedic Medical College And Hospital |
| Address |
DR G D POL FOUNDATION, YMT Ayurvedic Medical College And Hospital, 3rd Floor, surgery Dept, Sector- 4, Kharghar , Navi Mumbai
Raigarh
MAHARASHTRA
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9822221585 |
| Fax |
|
| Email |
dnyanesh7373@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohini Mukund Kedar |
| Designation |
PG Scholar |
| Affiliation |
Dr. G. D Pol, Foundation, YMT Ayurvedic Medical College And Hospital |
| Address |
DR G D POL FOUNDATION, YMT Ayurvedic Medical College And Hospital, 3rd Floor, surgery Dept, Sector- 4, Kharghar , Navi Mumbai
Raigarh
MAHARASHTRA
Raigarh
MAHARASHTRA
410210
India |
| Phone |
7972928110 |
| Fax |
|
| Email |
mohinikedar283@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr G D Pol, Foundation, YMT Ayurvedic Medical College And Hospital , Kharghar , Navi Mumbai , Maharashtra 410210 |
|
|
Primary Sponsor
|
| Name |
Dr. Mohini Kedar |
| Address |
DR G D POL FOUNDATION, YMT Ayurvedic Medical College And Hospital, 3rd Floor, shalya Dept, Sector- 4, Kharghar , Navi Mumbai
Raigarh
MAHARASHTRA
410210 |
| Type of Sponsor |
Other [self] |
|
|
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 Mohini Kedar |
DR G D POL FOUNDATION, YMT Ayurvedic Medical College And Hospital |
DR G D POL FOUNDATION YMT Ayurvedic Medical College And Hospital ,3rd Floor ,Shalya Tantra Department . Sector-4, Kharghar ,Navi Mumbai 410210
Raigarh
MAHARASHTRA |
7972928110
mohinikedar283@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| I nstitutional Ethics Committee Dr G D pol foundation YMT ayurvedic medical college and charitable hospital |
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: RAKTAJA-ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: R.T. 11/163-164, Procedure details: 750MG of purified sphatika dissolved in 60ml of lukewarm water. lubricate feeding tube no. 8 with lox 2% jelly, attach the tube to a 60cc syringe containing prepared sphatika drava. gently insert the tube into the rectum and administer the drug sslowly.)
(1) Medicine Name: sphatika, Reference: R.T.11/163-164, Route: Rectal, Dosage Form: Dravaka, Dose: 60(ml), Frequency: od, Duration: 3 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | 3% polidocanol injection | 1-3 ml of 3% polidocanol injection is taken into an insulin or tuberculin syringe with 26-30 gauze needle. with the help of slit proctoscope expose the internal hemorrhoids and inject polidocanol submucosally at the base of pile mass and not into the blood vessel directly. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients aged 18-60 years.
2)diagnosed with second degree haemorrhoids. |
|
| ExclusionCriteria |
| Details |
1)inflamed, strangulated or thrombosed hemorrhoids.
2)associated painful conditions like fistula, abscess, malignancy etc.
3)severe systemic illness eg diabetes, cardiac conditions etc
4)patients eith hb less than 10 gm percent.
5) pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Significant reduction in bleeding and size of pile mass.
2)Relief in subjective complaints.
3)Establishing sphatika drava basti as a reliable supportive treatment in 2nd degree internal haemorrhoids. |
0th day, 3rd day, 7th day, 15th day, 30th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
nil
|
nil |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
19/05/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
19/05/2026 |
| 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
|
The Present Study is a PG Thesis Topic By PG Scholar - DR Mohini Mukund Kedar and Guide Name - DR D.D. Chavan Title : RANDOMISED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFECT OF SPHATIKA DRAVA BASTI IN MANAGEMENT OF ARSHA W.S.R TO SECOND DEGREE HAEMORRHOIDS. According to inclusion and exclusion criteria Group A 37 patients and Group B 37 patients will be selected Group A ( intervention ) will be given shatika drava basti 60ml for 3 days. Group B ( control/ comparative ) will be given inj. polidocanol 1-3ml per pile mass. Total Duration of stud y is 1 year 6 months. |