| CTRI Number |
CTRI/2020/01/022661 [Registered on: 08/01/2020] Trial Registered Prospectively |
| Last Modified On: |
02/01/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic Management of Ajeerna (Indigestion). |
|
Scientific Title of Study
|
An open label clinical trial to evaluate the efficacy of Pachmeena Tonic in Ajeerna (Indigestion). |
| Trial Acronym |
PTI |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NOT REGISTERED ELSEWHERE |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gopesh Mangal |
| Designation |
Associate Professor, Department of Panchakarma |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG Department of Panchakarma,National Institute of Ayurveda
Jaipur
RAJASTHAN
302002
India |
| Phone |
8619849011 |
| Fax |
|
| Email |
gmangal108@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Himanshu Shekhar Tiwari |
| Designation |
Medical Advisor Multani Pharmaceuticals Ltd. |
| Affiliation |
Multani Pharmaceuticals Ltd. New Delhi |
| Address |
Medical Advisor Room, Pharmacy Division, Multani Pharmaceuticals Ltd. New Delhi
New Delhi
DELHI
110020
India |
| Phone |
9654350714 |
| Fax |
|
| Email |
dr.hstiwari@multani.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bharat Kumar C Padhar |
| Designation |
Lecturer |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG Department of Kayachikitsa,
National Institute of Ayurveda, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9638435942 |
| Fax |
|
| Email |
bcpadhar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Multani Pharmaceuticals Ltd |
|
|
Primary Sponsor
|
| Name |
Multani Pharmaceuticals Ltd |
| Address |
T-10 Okhla Phase II Road, Pocket W. okhla Industrial area, New Delhi-110020 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Gopesh Mangal |
National Institute of Ayurveda |
OPD No.2 (Panchakarma), National Institute of Ayurveda Hospital, Jorawar Singh Gate, Amer Road
Jaipur
RAJASTHAN |
8619849011
gmangal108@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Ayurveda IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K30||Functional dyspepsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Pachmeena Tonic |
Pachmeena tonic contains Nagarmotha (Cyperus rotundus), Haritaki (Terminalia chebula), Ajawain (Trachyspermum ammi), Maricha (Piper nigrum), Methika (Trigonella foenum-graecum), Chitraka (Plumbago zelyanica), Jeera Safed (Cuminum cyminum), Saunf (Foeniculum vulgare) and Lavanga (Syzygium aromaticum).
It will be administered in a dose of 10 ml orally thrice a day before meal with lukewarm water for 15 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects suffering from Ajeerna (Indigestion) and its related signs and symptoms such as fullness, bloating, nausea, gassy discomfort, loss of appetite, spasm and pain in the chest or abdomen for at least on two occasions in the preceding week and having normal hepatic and renal functions (LFT & RFT). |
|
| ExclusionCriteria |
| Details |
1. Subjects with persistent dyspepsia, vomiting, severe epigastric pain unintentional weight loss, iron deficiency anemia, gastro-intestinal bleeding, dysphasia, odynophagia, previous gastric surgery, epigastric mass, suspicious barium meal, peptic ulcer, and NSAID use.
2. Organic deformity or malignancy of the GI tract, significant systemic and psychological condition (s) which may hamper the study proceedings, conditions requiring immediate surgical intervention, Alcohol or drug abuse, pregnancy and lactating women.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Fullness of Stomach |
15 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in other subjective parameters |
30 Days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/01/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is an open label single centric, prospective interventional clinical study to evaluate the efficacy of Pachmeena tonic on 50 patients suffering from Ajeerna (Indigestion). The study will be conducted in Department of Panchkarma, NIA, Jaipur, Rajasthan. 50 patients of Ajeerna (Indigestion) will be randomly selected from OPD, NIA. Pachmeena tonic will be administered to Patients in a dose of 10 ml orally thrice a day before meal with lukewarm water for duration of 15 days. Follow up will be done for 15 days. The primary outcome measures will be to assess the efficacy of Pachmeena tonic in patients of Ajeerna (Indigestion) by assessing Improvement in Acid regurgitation on Day 0, Day 15th and after Follow up. The secondary outcome (other subjective parameters, as per validated symptom severity grading criteria for the patients with Ajeerna (Indigestion), developed by Hu WH, Wong YH et al. (J Gasteroenterol Hrpatol 2002; 17(5): 545-51.) will be assessed on Day 0, Day 15 and after Follow up (Day 30). A Performa shall be prepared incorporating the grading criteria for above mentioned parameters. |