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CTRI Number  CTRI/2023/09/057257 [Registered on: 05/09/2023] Trial Registered Prospectively
Last Modified On: 26/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Triphaladi kwatha and Aragawadhadikwatha in hyperacidity. 
Scientific Title of Study   A comparative clinical study to evaluate the efficacy of Triphaladi Kwatha and Aragwadhamrutadi 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 Lubna Sadaf Khan 
Designation  P.G Scholar Kayachikitsa 
Affiliation  SUMATIBHAI SHAH AYURVED MAHAVIDYALAYA MALWADI HADAPSAR PUNE 411028 
Address  MAMs Sumatibhai Shah Ayurved College Kayachikitsa department OPD No 2 Ground Floor Sane Guruji Arogya Kendra Malwadi Hadapsar Pune Maharashtra

Pune
MAHARASHTRA
411028
India 
Phone  9766247689  
Fax    
Email  lubnaskhan30@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sachinkumar Patil 
Designation  HOD Department of Kayachikitsa 
Affiliation  MAMs SUMATIBHAI SHAH AYURVED MALAVIDYALAYA MALWADI HADAPSAR PUNE 
Address  MAMs Sumatibhai Shah Ayurved College Kayachikitsa department OPD No 2 Ground Floor Sane Guruji Arogya Kendra Malwadi Hadapsar Pune Maharashtra

Pune
MAHARASHTRA
411028
India 
Phone  9822603608  
Fax    
Email  drsachinkumarpatil@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Lubna Sadaf Khan 
Designation  M.D. Scholar Kayachikitsa 
Affiliation  SUMATIBHAI SHAH AYURVED MAHAVIDYALAYA MALWADI HADAPSAR PUNE 411028 
Address  MAMs Sumatibhai Shah Ayurved College Kayachikitsa department OPD No 2 Ground Floor Sane Guruji Arogya Kendra Malwadi Hadapsar Pune Maharashtra

Pune
MAHARASHTRA
411028
India 
Phone  9766247689  
Fax    
Email  lubnaskhan30@gmail.com  
 
Source of Monetary or Material Support  
MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune 
 
Primary Sponsor  
Name  Dr Lubna Sadaf Khan 
Address  MAMs Sumatibhai Shah Ayurved College 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  
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 
Dr Lubna Sadaf Khan  Sane Guruji Arogya Kendra  Department of Kayachikitsa OPD NO 2 Ground floor And IPD Of Kayachikitsa First Floor Sane Guruji Arogya Kendra Pune Malwadi Hadapsar Pune 411028
Pune
MAHARASHTRA 		 9766247689

lubnaskhan30@gmail.com 
 
Details of Ethics Committee
Modification(s)  
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. Ayurveda Condition: AMLAPITTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Aragwadhamrutadi kwatha, Reference: Sahastrayoga, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Madhyabhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Koshna jala), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: TRIPHALADI KWATHA, Reference: GADANIGRAHA, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, 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  Age limit is from 18 to 60 years irrespective of Gender, Occupation, Religion and Economical condition.
2) Patients with the following symptoms of Urdhwaga Amlapitta for more than 1-2 month will be included according to Madhav Nidana (51/4-6)14 namely,
The symptoms of Amlapitta are as,
1. Chhardi (Vomiting)
2. Tikta-Amla-Udgara (Belching- Bitter/ Sour)
3. Shirashoola (Headache)
4. Utklesha/ Hrullas (Nausea)
5. Hruddaha (Burning in chest) 
 
ExclusionCriteria 
Details  1) Pregnant and Lactating women.
2) Patients with severe Vomiting and Diarrhoea and those who cannot take medicine orally.
3) Amlapitta along with other chronic disease and its associated complications.
4) Known case of Diabetes Mellitus.
5) Patients with gastric ulcers. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of Triphaladi Kwatha and Aragwadhamrutadi Kwatha in Urdhwaga Amlapitta  0th day 15th day 30th day 
 
Secondary Outcome  
Outcome  TimePoints 
To observe the adverse effects of Triphaladi Kwatha and Aragwadhamrutadi Kwatha  0th day 15th day 30th day 
 
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 4 
Date of First Enrollment (India)   11/09/2023 
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   Due to changing life style, dietary inconsistency, mental stress, aerated drinks, preserved food, spicy foods, suburbanization Amlapitta has become a common problem which affects day to day life. In contemporary science they included Amlapitta as symptoms of disease but in Ayurvedic classic they mentioned it as a separate disease. In modern science there is no adequate treatment available but in Ayurvedic classic various Samhitas mentioned effective management, hence there is a need of drug which will digest or metabolize the Saama Pitta and prevent the Agnimandya to break the Samprapti of Amlapitta.
Signs and symptoms of Amlapitta mentioned in the Ayurvedic texts are very similar to hyper acidity. The stomach normally secretes acid that is essential in the digestive process. The acid helps in the breakdown of food during digestion. When there is excess production of the acid
by gastric gland of the stomach, it results in the condition known as acidity.
This is an attempt to introduce Ayurveda based medicine in Amlapitta so here selected study on Amlapitta with Triphaladi Kwatha and Aragwadhamrutadi Kwatha.
Triphaladi Kwatha is mentioned in Gadnigraha9. The ingredients present in the formulation are Haritaki, Bibhitaki, Amalaki, Patolpatra, kutaki, 10. The most of the Dravya have Laghu, Ruksha Guna’s and Katu, Tikta, Kashaya Rasa, which acts against the excessive Drava and Tikshna Guna’s of Pitta, on the other hand they all play specific role in management of Mandagni.
Aragwadhamrutadi Kwatha is mention in Sahastrayoga11 which is a unique herbal combination of Aragwadha, Amruta, Haritaki, Khadira 12.
These drugs are useful in Amlapitta which are easily available, cost effective and show better palatability. Ample number of patients are available in day-to-day practice hence, selected this topic for study.
 
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