CTRI Number |
CTRI/2020/11/028940 [Registered on: 05/11/2020] Trial Registered Prospectively |
Last Modified On: |
28/10/2020 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda Other (Specify) [Langhan-Pachan with Shunthi Churna] |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Clinical Study of Laghvashan Langhan-Pachan With Shunthi Churna In Amlapitta |
Scientific Title of Study
|
A Compilation Of Ashtang Hridayokta Ama Chikitsa Siddhant And Randomized Controlled Trial Of The Efficacy Of Laghvashan Langhan-Pachan With Shunthi Churna In Amlapitta. |
Trial Acronym |
ELPS |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dhanshri Baburao Kumbhar |
Designation |
PG Scholar |
Affiliation |
Government Ayurveda College Nanded |
Address |
Department of Sanskrit Samhita Siddhant Government Ayurved College Nanded
Nanded MAHARASHTRA 431601 India |
Phone |
7741813888 |
Fax |
|
Email |
kdhanshri96@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Vd Chhaya D Manjarmkar |
Designation |
Assistant Professor |
Affiliation |
Government Ayurveda College Nanded |
Address |
Department of Sanskrit Samhita Siddhant Government Ayurved College Nanded
Nanded MAHARASHTRA 431601 India |
Phone |
9423438655 |
Fax |
|
Email |
chhayadingu@yahoo.in |
|
Details of Contact Person Public Query
|
Name |
Vd Chhaya D Manjarmkar |
Designation |
Assistant Professor |
Affiliation |
Government Ayurveda College Nanded |
Address |
Department of Sanskrit Samhita Siddhant Government Ayurved College Nanded
Nanded MAHARASHTRA 431601 India |
Phone |
9423438655 |
Fax |
|
Email |
chhayadingu@yahoo.in |
|
Source of Monetary or Material Support
|
Government Ayurved College and Hospital, Nanded |
|
Primary Sponsor
|
Name |
Dhanshri Kumbhar |
Address |
Department of Sanskrit Samhita Siddhant
Government Ayurved College and Hospital
Nanded |
Type of Sponsor |
Other [Government Ayurveda College 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 |
Vd Chhaya D Manjarmkar |
Government Ayurveda Hospital |
OPD no 3
Government Ayurveda Hospital
Wazirabad
Nanded Nanded MAHARASHTRA |
7741813888
kdhanshri96@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional 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, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Langhan-Pachan with Shunthi churna |
Dosage-Shunthi churna 5gram in Samankala with Laghvashan
Duration of therapy-7days
Anupana-Koshna jala |
Comparator Agent |
Shunthi Churna-5gram |
Dosage-Shunthi churna 5gram in Samankala with normal diet
Duration of therapy 7days
Anupana-Koshna jala |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Patients fulfilling the diagnostic criteria of Amlapitta that is with 19 grades out of 37 grades of symptoms will be diagnosed as Amlapitta |
|
ExclusionCriteria |
Details |
Patients suffering from other systemic diseases like Parinamshool, Food poisoning, Hypertension, Diabetes, Mental disorders
Patients who are steroid/any other dependent
Pregnant and lactating woman |
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To study the relief found in signs and symptoms of Amlapitta due to Amapachan |
7days |
|
Secondary Outcome
|
Outcome |
TimePoints |
To study the process and duration of Laghvashan Langhan-Pachan in Saam disease |
7days |
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
10/12/2020 |
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 Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
This study will be submitted in the form of Dissertation to Maharashtra University of Health Sciences as a compulsory part of Postgraduation Course |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
This study is a randomized control trial of efficacy of Laghvashan Langhan-Pachan with Shunthi Churna in Amlapitta with respect to Ashtang Hridayokta Ama Chikitsa Siddhant. Period of study is 7 days and follow up and assessment of therapy on 8th day. This study is conducted as a compulsory part of PG course at single centre. Primary outcome of this study is the relief found in signs and symptoms of Amlapitta due to Amapachan. The secondary outcome is to study the process and duration of Laghvashan Langhan-Pachan in Saam disease. |