| CTRI Number |
CTRI/2025/01/079202 [Registered on: 22/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Yoga & Naturopathy
Physiotherapy (Not Including YOGA)
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Ashvinimudra yogasana with bilva patra Kadha sitz bath Sweda in piles |
|
Scientific Title of Study
|
An open randomized controlled clinical study to evaluate efficacy of Ashwini Mudra along with Bilva patra kati avgah sweda in the management of Gudarsh wsr to grade 1 and 2 haemorrhoids |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RAJASHREE RAJESH KOLARKAR |
| Designation |
professor |
| Affiliation |
School of ayurveda, D.Y.Patil deemed to be University |
| Address |
School of ayurveda, D.Y.Patil deemed to be University, sector-7, Nerul, Navi Mumbai.
K.G.MITTAL AYURVED COLLEGE MUMBAI
Mumbai
MAHARASHTRA
400706
India |
| Phone |
9820064750 |
| Fax |
|
| Email |
rajashreekolarkar32@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RAJASHREE RAJESH KOLARKAR |
| Designation |
professor |
| Affiliation |
KG MITTAL AYURVED COLLEGE MUMBAI |
| Address |
NETAJI SUBHASH ROAD CHARNI ROAD MUMBAI 400002
MUMBAI
Mumbai
MAHARASHTRA
400002
India |
| Phone |
9820064750 |
| Fax |
|
| Email |
rajashreekolarkar32@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dwivedi Amarprakash |
| Designation |
Professor |
| Affiliation |
school of Ayurveda, D Y Patil Deemed to be University, Navi Mumbai |
| Address |
School of Ayurveda, D Y Patil Deemed to be University, Navi Mumbai
School of Ayurveda, D Y Patil Deemed to be University, Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA
400706
India |
| Phone |
9323097013 |
| Fax |
|
| Email |
amar.dwivedi@dypatil.edu |
|
|
Source of Monetary or Material Support
|
| DY Patil University School of Ayurved College in Nerul, Navi Mumbai 400706. Telephone No:022 3096 5888.OPD NO.3 SHALY TANTRA |
|
|
Primary Sponsor
|
| Name |
DR RAJASHREE KOLARKAR |
| Address |
School of Ayurveda Padm.D.Y.Patil deemed to be University School of Ayurveda sector 7 Nerul Navi Mumbai.400706 state:Maharashtra Country -India Ph.D.scholer |
| Type of Sponsor |
Other [PHD THESIS ] |
|
|
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 |
| Rajashree kolarkar rajashreekolarkargmailcom |
School of ayurveda D.Y.Patil deemed to be University |
opd no 3 surgery opd First Floor
Mumbai
MAHARASHTRA |
9820064750
0000000
diptyrk72@gmail.com This is my common email id |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee school of ayurved D Y Patil deemed University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: PILES, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | AVGAH SWED AND ASHWINI MUDRA | (Procedure Reference: HATHYOGRADIPIKA AND ASHTANGHRUDAY, Procedure details: Ashwini Mudra (horse gesture)
Technique 1: Rapid contraction
Its preferable to do empty stomach Sit in tub of bilva kadha in sitz bath position. Close the eyes and relax the whole body.
Become aware of the natural breathing.
Then take the awareness to the anus.
Rapidly contract the anal sphincter muscles for a few seconds without straining, then relax them. Confine the action to the anal area.
Contraction and relaxation should be performed 10 to 20 times, smoothly and rhythmically.
)
(1) Medicine Name: PANCHSAM CHURNA, Reference: SHARANGADHAR SAMHITA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Duration: 1 Months | | 2 | Intervention Arm | Procedure | - | avgah sweda | (Procedure Reference: avgah swed, Procedure details: HATHYOGRADIPIKA AND ASHTANGHRUDAY, Procedure details: Ashwini Mudra (horse gesture) Technique 1: Rapid contraction Its preferable to do empty stomach Sit in tub of bilva kadha in sitz bath position. Close the eyes & relax the whole body. Become aware of the natural breathing. Then take the awareness to the anus. Rapidly contract the anal sphincter muscles for a few seconds without straining, then relax them. Confine the action to the anal area. Contraction & relaxation should be performed 10 to 20 times, smoothly and rhythmically. ))
(1) Medicine Name: bilva kadha, Reference: ashtang hriday, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 5(NA), Frequency: bd, Duration: 3 Months |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Age group: 20 to 50 years,
Gender-Both, male and female.
Patients diagnosed with Grade 1 & 2 Haemorrhoids who are not receiving any other treatment
|
|
| ExclusionCriteria |
| Details |
Patients with Grade 3 and Grade 4 Haemorrhoids
Malignant conditions Ca Rectum and accelerated hypertensive, patient with systemic diseases like HIV, VDRL, CKD etc.
Patient with known complications of Haemorrhoids like Thrombosed, Strangulated Piles, Severe Anaemia etc.
Post Haemorrhoidectomy patients, Fissure, Fistula complex cases
Pregnant woman
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To evaluate the therapeutic efficacy of Ashwini mudra along with Bilva Patra kati Avgah sweda in the management of symptomssuch as Bleeding per rectum, Size of pedicle, Colour of pedicles, Constipation and Pain. |
0 15th DAY 30th DAY 45TH DAY 60TH DAY 75TH DAY 90TH DAY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 3. To establish Ashwini Mudra as an alternative regime for the management of first- and second-degree hemorrhoids and also for prevention from other ano rectal problems. |
THREE MONTHS |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="65" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/02/2025 |
| Date of Study Completion (India) |
06/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response (Others) - N
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response (Others) - N
- Who will be able to view these files?
Response (Others) - N
- For what types of analyses will this data be available?
Response (Others) - N
- By what mechanism will data be made available?
Response (Others) - N
- For how long will this data be available start date provided 18-04-2025 and end date provided 18-03-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - N
|
|
Brief Summary
|
The role of Ayurvedamanagement of Haemorrhoids has been proved by scientific studies. many people not only want to know how to heal haemorrhoids but how to heal them fast and naturally without any intervention and surgery. yoga naturopathy ayurveda have found cost effective lifestyle modification without surgery. purpose of the study is to create the awareness regarding modification of lifestyle for the prevention of pilesby regular practice of Yogic asanas, following pathya (Wholesome) Ahar (Diet) and viharas according to Ayurveda. also to find out the measures to prevent the advancement of disease into fourt degree which requirs compulsory surgical management. we can avoid further complications of haemorrhoid like thrombosed piles,severe anaemia,fistula by this therapy. |