CTRI Number |
CTRI/2019/08/020958 [Registered on: 29/08/2019] Trial Registered Prospectively |
Last Modified On: |
28/08/2019 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Role of Ayurveda medicine in AMLAPITTA |
Scientific Title of Study
|
A CLINICAL AND COMPARATIVE STUDY OF PIPPALI GHRIT AND PITTANTAK YOG ON AMLAPITTA |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Prof Kedar Lal Meena |
Designation |
Prof. and HOD department of Maulik Siddhant |
Affiliation |
National Institute of Ayurveda |
Address |
P G Department Maulik Siddhant
National Institute of Ayurveda
Jorawar Singh Gate
Amer Road
Jaipur
Rajasthan
302002
Jaipur RAJASTHAN 302002 India |
Phone |
9414638857 |
Fax |
|
Email |
drkedar01@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Prof Kedar Lal Meena |
Designation |
Prof. and HOD department of Maulik Siddhant |
Affiliation |
National Institute of Ayurveda |
Address |
P G Department Maulik Siddhant
National Institute of Ayurveda
Jorawar Singh Gate
Amer Road
Jaipur
Rajasthan
302002
Jaipur RAJASTHAN 302002 India |
Phone |
9414638857 |
Fax |
|
Email |
drkedar01@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Mahendra Kaswan |
Designation |
MD Scholar |
Affiliation |
National Institute of Ayurveda |
Address |
P G Department Maulik Siddhant
National Institute of Ayurveda
Jorawar Singh Gate
Amer Road
Jaipur
Rajasthan
302002
Jaipur RAJASTHAN 302002 India |
Phone |
9352763122 |
Fax |
|
Email |
kaswanmahendra@gmail.com |
|
Source of Monetary or Material Support
|
National Institute of Ayurveda, Madhav vilas palace, Amer road, Jaipur (PIN - 302002) |
|
Primary Sponsor
|
Name |
National Institute of Ayurveda |
Address |
National Institute of Ayurveda
Jorawar Singh Gate
Amer Road
Jaipur
Rajasthan
302002 |
Type of Sponsor |
Research institution and hospital |
|
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 Mahendra Kaswan |
National Institute of Ayurveda, Jaipur |
OPD No.21, P.G. Department of Maulik Siddhant and Samhita, National Istitute of Ayurved (Madhav Vilas Palace), Jorawar Singh Gate, Amer Road, JAIPUR - 302002 (Rajasthan Jaipur RAJASTHAN |
9352763122
kaswanmahendra@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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K273||Acute peptic ulcer, site unspecified, without hemorrhage or perforation, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Pippali Ghrit |
Pippali Ghrit 10 ml before meal with madhu twice a day for one month |
Intervention |
Pittantak Yog |
Pittantak Yog 1 gm before meal twice a day with water for one month |
|
Inclusion Criteria
|
Age From |
16.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1.Patient between 16years to 60years.
2.Patients of classical Amlapitta symptoms, irrespective of gender, caste, occupation and economic status.
3.Amlapitta of any dosha anubandha (associated doshah).
|
|
ExclusionCriteria |
Details |
1.Patient below 16 and above 60 years of age.
2.Patients with complication of acute or chronic gastritis like peptic ulcer any secondary infections or syndromes and medical emergencies.
3.Pregnant women or lactating mothers.
4.Any other systemic disorder than amlapitta.
5.Patient along with diabetes, HTN,COPD, Malignancy.
6.Complication which intervenes the course of treatment.
7.Patient on chemo and radiotherapy for malignancy.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Reduction in symptoms of Amlapitta. |
baseline, 15 days, 30 days. |
|
Secondary Outcome
|
Outcome |
TimePoints |
Measurement of Amlapitta (Acidity) severity. |
baseline, 15 days, 30 days |
|
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)
|
02/09/2019 |
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="0" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Yet to be published |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Amlapitta is a clinical condition which has become a common problem for most of the people in this modern era. Due to changed life style, increased pace of life, stress as well as changes in food habits. The prevalence rate of gastritis in india is around 10 millions. The risk factors like spicy food ,alcohol,aspirin,other NSAID’s ,or any gastric mucosa by inhibiting prostaglandins, gastric bi-carbonates and mucous secretions and alters the mucosal micro circulation. This produces symptom like heart burn, sour belching, acid eructation, anorexia and nausea. This leads to acute gastritis and if left unattended in the chronic stage it leads to gastric or duodenal ulcers, followed by perforation if untreated. The remedies in biomedicine are acid suppressive agents like H2 receptors antagonists, proton- pump inhibiters etc. These are working temporarily without any permanent solution as well as having adverse effects after long standing usage. Hence we shall consider the chikista sutra kaphapittahara vidhi described by Yogaratnakar to overcome the disease and the selected drug is the Pippali ghrit described by Chakradatta to overcome the disease and the selected drug Pippali ghrit containing pippali kawath, pippali kalak and gou ghrit and Pittantak yog containing Sitopala, Amrit dhara, Sudh Savaran gairik having seetvirya, madhura rasa and pittasamaka and agnidipaka guna. |