| CTRI Number |
CTRI/2024/03/063547 [Registered on: 04/03/2024] Trial Registered Prospectively |
| Last Modified On: |
01/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
RANDOMISED CONTROLLED CLINICAL STUDY OF EFFICACY OF PATOLVISHWADI KWATH WITH BHUNIMBADI KWATH IN THE MANAGEMENT OF URDHVAGA AMLAPITTA |
|
Scientific Title of Study
|
RANDOMISED CONTROLLED CLINICAL STUDY OF EFFICACY OF PATOLVISHWADI KWATH WITH BHUNIMBADI KWATH IN THE MANAGEMENT OF URDHVAGA 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 |
Pratiksha Vaijnath Waghmare |
| Designation |
PG Scholar |
| Affiliation |
Tilak Ayurved Mahavidyalaya,Pune |
| Address |
Department of Kayachikitsa,Tilak Ayurveda Mahavidyalaya,Rasta Peth,Pune 11
Pune
Maharashtra
411011
India
Seth Tarachand Ramnath Charitable Ayurvedic Hospital, 580/2,Rasta Peth,Pune-411011
Pune
MAHARASHTRA
411011
India |
| Phone |
8623900544 |
| Fax |
|
| Email |
dr.pratiksha123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSangeeta P Sawant |
| Designation |
Associate Professor Dept. of Kayachikitsa |
| Affiliation |
Tilak Ayurved Mahavidyalaya, Pune |
| Address |
Department of Kayachikitsa,Tilak Ayurveda Mahavidyalaya,Rasta Peth,Pune 11
Pune
Maharashtra
411011
India
Seth Tarachand Ramnath Charitable Ayurvedic Hospital,580/2,Rasta Peth,Pune-411 011
Pune
MAHARASHTRA
411011
India |
| Phone |
9130774107 |
| Fax |
|
| Email |
sangeetap14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSangeeta P Sawant |
| Designation |
Associate Professor Dept. of Kayachikitsa |
| Affiliation |
Tilak Ayurved Mahavidyalaya, Pune |
| Address |
Department of Kayachikitsa,Tilak Ayurveda Mahavidyalaya,Rasta Peth,Pune 11
Pune
Maharashtra
411011
India
Seth Tarachand Ramnath Charitable Ayurvedic Hospital,580/2,Rasta Peth,Pune-411 011
Pune
MAHARASHTRA
411011
India |
| Phone |
9130774107 |
| Fax |
|
| Email |
sangeetap14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tilak Ayurved Mahavidyalaya,Rasta Peth,Pune-11 |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalaya Pune |
| Address |
Rasta Peth Pune 11 |
| Type of Sponsor |
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 Pratiksha Vaijnath Waghmare |
Tilak Ayurved Mahavidyalaya,Rasta Peth,Pune |
Seth Tarachand Ramnath Charitable Ayurvedic Hospital,Kayachikitsa Department,OPD No.5,Rasta Peth, Pune-11
Pune
MAHARASHTRA |
8623900544
dr.pratiksha123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Tilak Ayurved Mahavidyalaya, Pune and Seth Tarachand Ramanath Charitable Ayurvedic Hospital, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K297||Gastritis, unspecified. Ayurveda Condition: URDHVAGATA-AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bhunimbadi Kwath , Reference: Yogratnakara , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -koshnajal ), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Patolvishwadi Kwath , Reference: Chakradatta , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -koshnajal ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling the diagnostic criteria which are based on sign and symptoms of amlapitta
Age group from 18-60 years
Patients from either gender will be taken
|
|
| ExclusionCriteria |
| Details |
History of any other chronic Systemic disorders.
History of any other addictions like chronic alcohol induced hyperacidity. |
|
|
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
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduced in symptoms like Vomiting, Nausea, Heartburn, Headache, Anorexia, Bloating, Abdominal discomfort |
Baseline 7th day 14th day 21th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduced in Symptoms like Vomiting,Nausea, Chestburn, Headache, Anorexia, Heaviness in abdomen & bloating.
|
45days |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
15/03/2024 |
| 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
|
Amlapitta,a gastrointestinal sickness on by Ama’s vitiation of Pitta and Kapha, is a condition that affects many people on a regular basis.Ayurveda is founded on two tenets: upholding swasthsyaswasthya rakakshanam and curing vikara of the aatura.However, man cannot follow dincharya and rutucharya in the twenty-first century.It may result in a constant shift in one’s lifestyle, including bad eating patterns, inconsistent sleeping patterns, mental stress and shift work.Any disease, according to Ayurveda,can arise from the vitiation of Agni,dosha,mala and dhatu. In addition to being in charge of Ayu(age),Varna(colour),Swasthya(health),Utsaha(excitement),Upachaya,Prabha,Oja,Teja and Agni also plays a crucial part in the etio pathogenesis of all human beings. |