| CTRI Number |
CTRI/2023/07/055717 [Registered on: 26/07/2023] Trial Registered Prospectively |
| Last Modified On: |
25/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A single arm clinical trial to evaluate efficacy of patol-sunthi yoga with Madhu in the management of urdhwaga amlapitta with special reference to guna vishesh siddhanta. |
|
Scientific Title of Study
|
A single arm clinical trial to evaluate efficacy of patol-sunthi yoga with madhu in the management of urdhwaga amlapitta with special reference to guna vishesh siddhanta. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rohini Bhaurao Dhokane |
| Designation |
MD Scholar Ayurved Samhita And Siddhant(Ayurved) |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
Sane Guruji Arogya Kendra, Department of Ayurved Samhita And Siddhant, MAMs Sumatibhai Shah Ayurved Mahavidyalaya, Malwadi, Hadapsar, Pune, Maharashtra, India.
Pune
MAHARASHTRA
411028
India |
| Phone |
9145322452 |
| Fax |
|
| Email |
dr.rohinidhokane@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nilesh Kulkarni |
| Designation |
HOD Professor |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
Sane Guruji Arogya Kendra, Department of Ayurved Samhita And Siddhant, MAMs Sumatibhai Shah Ayurved Mahavidyalaya, Malwadi, Hadapsar, Pune, Maharashtra, India.
Pune
MAHARASHTRA
411028
India |
| Phone |
8805335512 |
| Fax |
|
| Email |
prof.dr.nileshkulkarni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nilesh Kulkarni |
| Designation |
HOD Professor |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
Sane Guruji Arogya Kendra, Department of Ayurved Samhita And Siddhant, MAMs Sumatibhai Shah Ayurved Mahavidyalaya, Malwadi, Hadapsar, Pune, Maharashtra, India.
Pune
MAHARASHTRA
411028
India |
| Phone |
8805335512 |
| Fax |
|
| Email |
prof.dr.nileshkulkarni@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sane Guruji Arogya Kendra,Malwadi,Hadapsar,Pune 411028 |
|
|
Primary Sponsor
|
| Name |
Sane Guruji Arogya Kendra |
| Address |
Sane Guruji Arogya Kendra, Department Of Ayurved Samhita And Siddhant, Malwadi, Hadapsar, Pune, Maharashtra, India. 411028 |
| 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 Rohini Bhaurao Dhokane |
Sane Guruji Arogya Kendra |
Department of Ayurved Samhita And Siddhant, MAMs Sumatibhai Shah Ayurved Mahavidyalaya, Malwadi, Hadapsar, Pune, Maharashtra, India. 411028
Pune
MAHARASHTRA |
9145322452
dr.rohinidhokane@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAMs S.S.A.M. & Ayurved Hospital Sane Guruji Arogya Kendra Hadapsar, Pune |
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: URDHVAGATA-AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Patol Sunthi Madhu Yog, Reference: Gadnigrah Sanhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: Patol Sunthi - 1gm and Madhu-2gm follow up on 15th and 21st day. |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient at list any 3 of the following symptoms of Urdhwaga Amlapitta for more than 1 months will be included according to Madhav nidhana (51/4-6) namely.
The symptoms of Amlapitta are as,
1. Chhardi (Vommiting)
2.Shirashoola (Headache)
3. Tikta -Amla -Udgara (belching -Bitter/Sour test)
4.Kanthdah (Burning sensation in throat)
5. Kukshidaha (Burning sensation in the upper abdomen)
6.Hastapadadaha (Burning sensation in the plams and soles)
7.Aruchi (Lose of test)
8.Utkesh/Hrullasa (Nausea)
9.Hruddaha (Burning sensation in chest)
10.Kandu (Itching)
11.Mandala
12.Pidaka
13.Avipak (Indigestion)
14.Jwara (fever) |
|
| ExclusionCriteria |
| Details |
1. Pregnant and Lactating women.
2. Amlapitta along with other chronic disease and its associated complications. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate efficacy of patol-sunthi madhu yoga in the management of urdhwaga amlapitta symptoms. |
Follow up assessment of 15th(I.e. after 2 week) & 21st day(I.e. after 3 week) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate efficacy of patol-sunthi yoga with madhu in the management of urdhwaga amlapitta with special reference to guna vishesh siddhanta. |
Follow up assessment of 15th & 21st day. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
07/08/2023 |
| 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 A single arm clinical trial to evaluate efficacy of Patol-Sunthi Yoga with Madhu in the management of Urdhwaga Amlapitta with special reference to Guna Vishesh Siddhanta. All information collected from a clinical study will be presented in the form of graph, charts, and tables. All the observed data will be subjected to rigid statistical analysis and will be analyzed. All the data from CRF, Questionnaire and Visual Analogue Scale will be recorded in MS-Excel and will be analyzed using appropriate statistical methods. The results will be tabulated as per the standard protocol and the result will be subjected to statistical analysis. Conclusion will be drawn based on overall assessment, tabulation, Statistics, and graphical presentation of data. |