| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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. |