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CTRI Number  CTRI/2024/06/069455 [Registered on: 25/06/2024] Trial Registered Prospectively
Last Modified On: 20/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Management]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Managing Acidity With Unripe Bilwa Phala Panaka As Diet Supplement  
Scientific Title of Study   Clinical Study To Evaluate The Add On Effectiveness Of Apakwa Bilwa Phala Panaka As Pathya In The Management Of Amlapitta  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Trishul Dev T A 
Designation  Post Graduate Scholar  
Affiliation  Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital, Hassan, Karnataka  
Address  Department Of Swasthavritta Evam Yoga, Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital, BM Road, Thanniruhalla , Hassan - 573201, KARNATAKA, India

Hassan
KARNATAKA
573201
India 
Phone  7829736003  
Fax    
Email  devtrishul868@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shivakumar  
Designation  Associate Professor  
Affiliation  Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital, Hassan, Karnataka  
Address  Department Of Swasthavritta Evam Yoga, Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital, BM Road, Thanniruhalla , Hassan - 573201, KARNATAKA, India

Hassan
KARNATAKA
573201
India 
Phone  9886259437  
Fax    
Email  drshiva.k@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shivakumar  
Designation  Associate Professor  
Affiliation  Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital, Hassan, Karnataka  
Address  Department Of Swasthavritta Evam Yoga, Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital, BM Road, Thanniruhalla , Hassan - 573201, KARNATAKA, India

Hassan
KARNATAKA
573201
India 
Phone  9886259437  
Fax    
Email  drshiva.k@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital ,BM Road,Thanniruhalla,Hassan-573201,Karnataka,India 
 
Primary Sponsor  
Name  Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital  
Address  Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital ,BM Road,Thanniruhalla,Hassan-573201,Karnataka,India 
Type of Sponsor  Private medical college 
 
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 Trishul Dev T A  Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital  Department Of Swasthavritta Evam Yoga, opd number 9,Sri Dharmasthala Manjunatheswara College Of Ayurveda And Hospital,BM Road,Thanniruhalla,Hassan-573201
Hassan
KARNATAKA 		 7829736003

devtrishul868@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital, Hassan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K210||Gastro-esophageal reflux disease with esophagitis. Ayurveda Condition: AMLAPITTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Kamadudha Rasa , Reference: Ayurveda sara sangraha , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Apakva Bilwa phala panaka/ Bilwa sharbath, Reference: Ayurveda Sara Sangraha, Route: Oral, Dosage Form: Panak/ Sharbat, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Water), Additional Information: -Bilwa phala panaka is also called as bilwa sharbath as Apakwa bilwa phala has deepana,pachana,amahara, vatakapha hara karma helps in overcoming the condition of Amlapitta and bringing agni to normalcy thereby clearing the basic samprapti of amlapitta wherein agnimandya will be in the initial stage.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.The subjects of age group of 18-60 years will be selected.
2.The subjects of all gender and Socioeconomic status will be selected.
3.Subjects who are willing to sign the informed consent form.
 
 
ExclusionCriteria 
Details  1.Pregnant and lactating mother
2.Known cases of carcinoma of throat, esophageal carcinoma, carcinoma of stomach.
3.Known case of gastric and duodenal ulcer.
4.Known case of Type 2 Diabetes mellitus.

 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Hrit daha (burning sensation in heart)
2.Kantha daha (burning sensation in abdomen)sensation in throat)
3.Kukshi daha
4.Tiktodgara (bitter belching)
5.Amlodgara (sour belching)
6.Avipaka (indigestion)
7.Aruchi (tastelessness)
8.Udara gourava (heaviness in abdomen)
9.Utklesha (nausea)
 		 15 days 
 
Secondary Outcome  
Outcome  TimePoints 
Gastrointestinal Symptom Rating Scale (GSRS Scale)  15 days 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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/ Phase 3 
Date of First Enrollment (India)   01/07/2024 
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="0"
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  

Amlapitta is a commonly encountered disease of the Annavaha Srotas. Improper food habits and busy stressful lifestyle are the main factors which have led to its increased prevalence. No medicine is equal to Ahara and is termed as Mahabhaishajya As ayurveda considers pathya itself as medicine If a person ignores the concept of Pathya-Apathya and consumes apathya, illness will never leave the body. So only the diet is given the prime importance in the treatment of disease. The dravya used for study is apakva bilwa phala. The Deepana, Pachana and Amahara4 property of the dravya helps in overcoming the condition of amlapitta and bringing the agni to normalcy, thereby clears the basic samprapti of amlapitta wherein Agnimandya is in the initial stage. Sharkara due to its Pittahara and Dahahara karma helps in decreasing the symptoms of Amlapitta. apakva bilwa phala as its availability is throughout the year and is cost-effective, can be converted into various palatable formulations like syrup, squash. Apakwa bilwa phala majja is very difficult to extract on daily basis, so it is transformed into syrup form, which is ready to use in the form of panaka by mixing it with water which people commonly like to consume due to its taste.  The present study will be an open label, double arm clinical study using the Convenience (non-random) sampling technique

A minimum of 48 subjects will be selected who are diagnosed with Amlapitta and fulfilling inclusion criteria will be recruited., 24 for each group that is for study group -24 subjects and control group - 24 subjects 

Study group - Shamana chikitsa with Kamadudha rasa two tablets twice daily, before food. Along with it Apakwa Bilwa phala panaka is given in the dosage of 50ml [20ml syrup+ 30ml plain water] in empty stomach twice daily for 15 days. Data will be collected before and after the intervention.

Control group - Shamana chikitsa with Kamadudha rasa two tablets twice daily, is given before food, for 15 days. Data will be collected before and after the intervention.

 
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