| CTRI Number |
CTRI/2025/04/085031 [Registered on: 17/04/2025] Trial Registered Prospectively |
| Last Modified On: |
06/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of Guduchyadi gana siddha ksheera enema in Urdhwaga Amlapitta(hyperacidity) |
|
Scientific Title of Study
|
A single arm clinical study to evaluate the efficacy of Guduchyadi Gana Siddha Ksheera Basti in the managemnet of Urdhwaga 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 Radhika shriramji Jethliya |
| Designation |
M.D. scholar Panchakarma |
| Affiliation |
MAMs Sumatibhai shah ayurved mahavidyalaya, Pune |
| Address |
Panchakarma Department, OPD no. 06,Ground floor,MAMs Sumatibhai shah ayurved mahavidyalaya, malwadi, hadapsar, pune 411028
Maharashtra, India
Pune
MAHARASHTRA
411028
India |
| Phone |
9730837305 |
| Fax |
|
| Email |
radhikajethliya45@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka Keram |
| Designation |
Assistant Professor of panchakarma |
| Affiliation |
MAMs Sumatibhai shah ayurved mahavidyalaya, Pune |
| Address |
Panchakarma Department, OPD no. 06, Ground floor,MAMs Sumatibhai shah ayurved mahavidyalaya, malwadi, hadapsar, pune 411028
Maharashtra, India
Pune
MAHARASHTRA
411028
India |
| Phone |
8485022857 |
| Fax |
|
| Email |
drpriyankakeram@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Radhika Jethliya |
| Designation |
M. D. Scholar Panchakarma |
| Affiliation |
MAMs Sumatibhai shah ayurved mahavidyalaya, Pune |
| Address |
Panchakarma Department, OPD no.06,Ground floor,MAMs Sumatibhai shah ayurved mahavidyalaya, malwadi, hadapsar, pune 411028
Maharashtra, India
Pune
MAHARASHTRA
411028
India |
| Phone |
9730837305 |
| Fax |
|
| Email |
radhikajethliya45@gmail.com |
|
|
Source of Monetary or Material Support
|
| department of panchakarma, Sane guruji arogya kendra, malwadi, hadapsar, pune 411028 |
|
|
Primary Sponsor
|
| Name |
Sane guruji Aarogya Kendra |
| Address |
Sane Guruji Aarogya kendra, malwadi, hadapsar, pune 411028
Maharashtra, India |
| 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 Radhika shriramji Jethliya |
Sane Guruji Aarogya kendra |
OPD No.6, ground floor, Department of Panchakarma, ground floor,sane guruji kendra, malwadi, hadapsar, pune 411028
Pune
MAHARASHTRA |
9730837305
radhikajethliya45@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAMs Sumatibhai Shah Ayurved Mahavidyalaya & Sane guruji Arogya Kendra institutional ethical 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: URDHVAGATA-AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Basti Arha.
patients having urdhwaga amlapitta more than a year is to be considered (chronic cases only)
patients having cardinal symptoms like udardaha, hrutkanthadaha, tiktoamloudgar will be selected for study |
|
| ExclusionCriteria |
| Details |
patients having symptoms of Urdhwaga Amlapitta suffering from other systemic disease which interefere the intervention.
diagnosed patient of gastric ulcer and duodenal ulcer are excluded.
pregnant women.
those who have the history of lactose intoleranceare excluded. (milk and milk products allergy)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Guduchyadi Gana Siddha ksheera basti in Urdhwaga Amlapitta |
treatment will be given for 7 days. Patient will be assessed on 0 and 7th day and follow up on 15th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
01/05/2025 |
| 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
|
This is single arm clinical study to evaluate the efficacy of Guduchyadi Gana Siddha Ksheera Basti In Urdhwaga Amlapitta . Basti is given for 7 days and observation will be drawn from outcome of the patient. |