FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.  
Close