| CTRI Number |
CTRI/2025/09/095406 [Registered on: 25/09/2025] Trial Registered Prospectively |
| Last Modified On: |
24/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Trial To Study The Effect Of 2 Therapies or Procedures In Participants Or Patients i.e. Intervention Of Enema Therapy and Purgative Therapy With The Drug Named Trivrutta Avleh For Reduction Of Signs and Symptoms Specifically In Hyperacidity Patients. |
|
Scientific Title of Study
|
Comparative Study Of Pittaghna Asthapan Basti And Virechan With Trivrutta Leh In Amlapitta |
| 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 Shruti Bagewadikar |
| Designation |
Phd. Scholar |
| Affiliation |
Bharati Vidyapeeth College of Ayurved and Hospital |
| Address |
Department of Panchakarma, Bharati Vidyapeeth(deemed to be university) College of Ayurved and Hospital, Dhankawadi,Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9403850065 |
| Fax |
|
| Email |
shruti.bagewadikar@bharatividyapeeth.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shubhangi Katkar |
| Designation |
BAMS, M.D.,PhD. Panchakarma |
| Affiliation |
Bharati Vidyapeeth College of Ayurved and Hospital |
| Address |
Department of Panchakarma, Bharati Vidyapeeth(deemed to be university) College of Ayurved and Hospital, Dhankawadi,Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9850904374 |
| Fax |
|
| Email |
shubhangi.katkar@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shruti Bagewadikar |
| Designation |
Phd. Scholar |
| Affiliation |
Bharati Vidyapeeth College of Ayurved and Hospital |
| Address |
Department of Panchakarma, Bharati Vidyapeeth(deemed to be university) College of Ayurved and Hospital, Dhankawadi,Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9403850065 |
| Fax |
|
| Email |
shruti.bagewadikar@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Bharati VIdyapeeth Deemed to be University College of Ayurved and Hospital,Dhankawadi, Katraj,Pune-411043,Mharashtra, India |
|
|
Primary Sponsor
|
| Name |
Dr Shruti Bagewadikar |
| Address |
Bharati Vidyapeeth deemed to be University College of Ayurved and Hospital, OPD no. 21, Department of Panchakarma, Dhankawadi,Katraj, Pune- 411043,Maharashtra,India |
| 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 Shruti Bagewadikar |
Bharati Vidyapeeth Deemed to be University, College of Ayurved and Hospital |
Bharati Vidyapeeth Deemed to be University,Bharati Ayurved hospital, Department of Panchakarma OPD No. 21, Dhankawadi, Katraj,Pune
Pune
MAHARASHTRA |
9403850065
shruti.bagewadikar@bharatividyapeeth.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth(Deemed to be University)College Of Ayurved-Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K219||Gastro-esophageal reflux disease without esophagitis. Ayurveda Condition: AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-कर्म Pradhan Karma | (Procedure Reference: Kasture, Procedure details: Pradhan Karma:
At 9:30 am administration of Trivrutta leha 60-80-100 gm according to Mridu,
Madhyam and Krura Kostha.
Patient will be observed after administration of Virechana drug.
Patient will be observed for Vegas to be started, Sarvadehika Lakshana (Symptoms)will be observed and recorded.
Patient will be observed for Samyak Vegas and Upavegas.
Kaphant Virechana vega will be observed.
)
(1) Medicine Name: Trivrut Leh, Reference: Astanaga Hridya, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 60(g), Frequency: od, Duration: 1 Days | | 2 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म Pradhan Karma | (Procedure Reference: Kasture, Procedure details: The patient will be kept in left lateral position, the anus and Basti Netra / enema can, catheter will be lubricated with oil, Basti Kalpa of 640 ml- 960 ml(Niruha ) at lukewarm temperature will be administered with the help of Basti Putaka ( Enema can and Bastinetra with polythene bag )
(1) Medicine Name: PITTAGHNA ASTHAPAN BASTI, Reference: Charak Siddhi Stana, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 640(ml), Frequency: od, Duration: 8 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients showing classical signs and symptoms of Amlapitta for more than one year will be selected for study.
2.Either Male or female patients fit for virechan and asthapan basti.
|
|
| ExclusionCriteria |
| Details |
1.Patients with complications like cardiac problems, fissure, bleeding piles, malignant conditions.
2.Pregnant women and Lactating mothers will be excluded.
3.Patients above 50yrs and below 18 yrs.
4.Contraindications of virechan and Niruh basti.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of Signs and Symptoms of Amla Pitta |
Baseline, 15th day, 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIl |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 |
|
Date of First Enrollment (India)
|
24/11/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Incidencs of Amlapitta are increasing day by day in todays population due to change in lifestyle. Amlapitta has references to virechan with trivrutta leh which we vaidyas incorporate in our everyday lives. Virechan therapy uses purgative medications in order to help your body get rid of toxins through rectum. Since Trivrutta is considered as sukh virechak it is usually made of avleh to make it more palatable for larger portions.Use of Asthapan Basti in the treatment of Amlapitta is mentioned in Bhaishjya Ratnawali, Yogratnakar, Chakradatta and Vangasen in detailed manner. Amla pitta has references to Virechana karma as well as Asthapan basti karma, here we are analysing its comparative effect. However it is believed that in addition to Virechan, Asthpan Basti can also be helpful in Amlapitta for people who are unwilling or unable to get virechan and snehpana. |