| CTRI Number |
CTRI/2022/05/042419 [Registered on: 09/05/2022] Trial Registered Prospectively |
| Last Modified On: |
08/05/2022 |
| 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 comparative clinical study to evaluate the efficacy of Dashanga Kwatha and Nagara Ativishadi Kwatha in Hyperacidity |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of Dashanga Kwatha and Nagara Ativishadi Kwatha in the management of Urdhwaga Amlapitta |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukul Shamrao Pawar |
| Designation |
M.D. Scholar Kayachikitsa |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya, Malwadi, Hadapsar,Pune |
| Address |
Department Of Kayachikitsa,
OPD Division, OPD no.2,
Ground floor, Sane Guruji Arogya Kendra,Malwadi,Hadapsar,Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
8149846431 |
| Fax |
|
| Email |
dr.mukulsp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachinkumar Sahebrao Patil |
| Designation |
Head Of Department Of Kayachikitsa |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya, Malwadi, Hadapsar,Pune |
| Address |
Department Of Kayachikitsa,
OPD Division, OPD no.2,
Ground floor, Sane Guruji Arogya Kendra,Malwadi,Hadapsar,Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9822603608 |
| Fax |
|
| Email |
drsachinkumarpatil@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukul Shamrao Pawar |
| Designation |
M.D. Scholar Kayachikitsa |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya, Malwadi, Hadapsar,Pune |
| Address |
Department Of Kayachikitsa,
OPD Division, OPD no.2,
Ground floor, Sane Guruji Arogya Kendra,Malwadi,Hadapsar,Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
8149846431 |
| Fax |
|
| Email |
dr.mukulsp@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune |
|
|
Primary Sponsor
|
| Name |
Dr Mukul Shamrao Pawar |
| Address |
Department Of Kayachikitsa,
OPD Division, OPD no.2,
Ground floor, Sane Guruji Arogya Kendra,Malwadi,Hadapsar,Pune |
| 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 Mukul Shamrao Pawar |
Sane Guruji Arogya Kendra, Malwadi, Hadapsar, Pune |
Department Of Kayachikitsa,
OPD Division, OPD no.2,
Ground floor, Sane Guruji Arogya Kendra,Malwadi,Hadapsar,Pune
Pune
MAHARASHTRA |
8149846431
dr.mukulsp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITEE |
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 | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Nagara Ativishadi Kwatha, Reference: Kashyap samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Madhyabhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Koshnajala), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dashanga Kwatha, Reference: Bharat Bhaishajya Ratnakara, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Madhyabhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Koshnajala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Age limit is from 18 to 60 years
irrespective of Gender, Occupation, Religion and
Economical condition.
2) Patients with at least 3 symptoms of Urdhwaga Amlapitta for more than 1-2 months will
be included according to Madhava Nidana (51/4-6)16 namely,
The symptoms of Amlapitta are as,
1. Chhardi (Vomiting)
2. Tikta-Amla-Udgara (Belching- Bitter/ Sour)
3. Kanthadaha (Burning sensation in throat)
4. Hruddaha (Burning sensation in the chest)
5. Kukshidaha (Burning sensation in the upper abdomen)
6. Shirashoola (Headache)
7. Hastapadadaha (Burning sensation in the palms and soles)
8. Aruchi (Loss of taste)
9. Utklesha/ Hrullasa (Nausea) |
|
| ExclusionCriteria |
| Details |
1) Pregnant and Lactating women.
2) Patients with severe Vomiting and Diarrhoea and those who can’t take medicine orally.
3) Amlapitta along with other chronic disease and its associated complications.
4) Known case of Diabetes Mellitus. |
|
|
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 |
| To compare the effect of Dashanga Kwatha with Nagara Ativishadi Kwatha |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the adverse effect of Dashanga Kwatha and Nagara Ativishadi Kwatha |
30 days |
|
|
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 |
|
Date of First Enrollment (India)
|
10/05/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A comparative clinical study to evaluate the eficacy of Dashanga Kwatha and Nagara Ativishadi Kwatha in Urdhwaga Amlapitta corelated with modern disease like GERD. Total 60 patients of Urdhwaga Amlapitta have been selected for the study divided in two groups. Dashanga Kwatha 20 ml BD at madhyabhakta kala will be given to patients included in Group -A for 30 days and Nagara Ativishadi Kwatha 20 ml BD at madhyabhakta kala will be given to patients included in Group-B for 30 days . Objectives of the study - To evaluate the comparative efficacy of Dashanga Kwatha and Nagara Ativishadi Kwatha in Urdhwaga Amlapitta . The obtained results will be compared in between two formulations and will be discussed accordingly. conclusion will be drawn based on overall assesment of data. |