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CTRI Number  CTRI/2025/02/081049 [Registered on: 21/02/2025] Trial Registered Prospectively
Last Modified On: 20/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A clinical trial to study the effect of enema therapy in chronic acid reflux. 
Scientific Title of Study   Open label single arm clinical study to evaluate the effectiveness of Pittaghna Kala Basti in the management of Chirotha 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 Mohana Sundarai M 
Designation  PG Scholar 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital 
Address  Department of Panchakarma Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital Thanniruhalla Hassan Karnataka India

Hassan
KARNATAKA
573201
India 
Phone  8012522110  
Fax    
Email  monumj9596@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr B A Lohith 
Designation  Professor 
Affiliation  SDM College of Ayurveda and Hospital 
Address  Department of Panchakarma Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital Thanniruhalla Hassan Karnataka India

Hassan
KARNATAKA
573201
India 
Phone  9886749168  
Fax    
Email  drlohithpk@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr B A Lohith 
Designation  Professor 
Affiliation  SDM College of Ayurveda and Hospital 
Address  Department of Panchakarma Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital Thanniruhalla Hassan Karnataka India


KARNATAKA
573201
India 
Phone  9886749168  
Fax    
Email  drlohithpk@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital Thanniruhalla Hassan Karnataka India 573201 
 
Primary Sponsor  
Name  SDM College of Ayurveda and Hospital 
Address  Thanniruhalla, Hassan 573201 
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 Mohana Sundarai  Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital  OPD and IPD under all the departments of Sri Dharmasthala Manjunatheshwara College of Ayurveda & Hospital, Thanniruhalla, Hassan, Karnataka, India
Hassan
KARNATAKA 
8012522110

monumj9596@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL  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
1Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Charaka Samhita SiddhiSthanam 10/21, Procedure details: Niruha Basti with Pittaghna Basti and Anuvasana with Dadimadi Ghrita.)
(1) Medicine Name: Pittaghna Basti, Reference: Charaka Samhita SiddhiSthanam 10/21, Route: Rectal, Dosage Form: Not Applicable, Dose: 620(ml), Frequency: od, Duration: 10 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Chronicity more than 6 months
2. Age group hetween 18-60 years either gender
3. Participants fit for Basti Karma
4. Participants who are willing to participate and sign the informed consent form.
 
 
ExclusionCriteria 
Details  1. Pregnant women
2. Patients with history of systemic illness like diabetic mellitus and uncontrolled hypertension, immunodeficiency disorders like AIDS, and Carcinoma
3. Patients with Renal diseases, heart diseases, known case of hiatus hernia.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessment will be based on Samyak Basti Lakshanas, Retention time of Basti Dravya, and Number of Vegas for the procedure; and Avipaka (indigestion), Utklesha(nausea), Tikta-amla udgara (spicy-sour belching), Hrit-kantha daha (burning sensation in chest and throat) and Epigastric tenderness are to be assessed for Chirotha Amlapitta.

 
10days 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in ease of lifestyle  25days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   18/03/2025 
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 Yet Recruiting 
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 one of the commonest prevalent diseases in society, primarily influenced by factors such as poor dietary habits, lifestyle changes, poor maintenance of food timings and prolonged medication. It predominantly affects younger and middle-aged individuals, with a prevalence rate of 78.8% in the general population, notably 48.9% for acute cases and 29,9% for chronic cases’. In India, 3 in 869 individuals are suffering from the disease .77.2% among them are adult aged 19 to 26 years. Despite the abundance of available treatments in all medical systems, none can fully cure the condition, leading to recurrent symptoms and dependence on medications, often proceeds to chronic Amlapitta. This highlights the need for effective preventive measures. Hence, the disease is being chosen for the study.

Basti stands out as the premier treatment for Vata disorders, but its efficacy extends equally to Pitta, Kapha, and Rakta imbalances. Specifically addressing Pitta imbalances, Charaka recommends the administration of five to six Anuvasana Basti. Even though Basti exits the intestine quickly, the potency of the medications still spreads throughout the interneurons of the gut, exerting an impact on the enteric nervous system. Notably, he emphasizes the use of Pittaghna Basti formulations, which possess qualities such as Tikta. Madhura Rasa. Snigdha and Sheeta Basti treatment is given the higher prevalence of chronic cases, there’s a significant focus on addressing them. Specifically, for Chirotha Amla Pitta Asthapana and Anuvasana Bastis are recommended. Hence, Pittaghna Basti may be effective in alleviating the condition.
 
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