| CTRI Number |
CTRI/2023/12/060576 [Registered on: 20/12/2023] Trial Registered Prospectively |
| Last Modified On: |
20/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
clinical study of charak digestive syrup in the management of Amplapitta |
|
Scientific Title of Study
|
open labelled clinical study of charak digestive syrup in the management of Amplapitta |
| 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 Jai Kiran Kini |
| Designation |
Associate Professor Dr. G. D. Pol foundations YMT Ayurvedic Medical College |
| Affiliation |
Dr. G. D. Pol foundations YMT Ayurvedic Medical College |
| Address |
Dr. G. D. Pol foundations YMT Ayurvedic Medical College institutional area sector 4 Kharghar navi Mumbai Maharashtra
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9869046901 |
| Fax |
02227749895 |
| Email |
vd.jaikini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jai Kiran Kini |
| Designation |
Associate Professor Dr. G. D. Pol foundations YMT Ayurvedic Medical College |
| Affiliation |
Dr. G. D. Pol foundations YMT Ayurvedic Medical College |
| Address |
Dr. G. D. Pol foundations YMT Ayurvedic Medical College institutional area sector 4 Kharghar
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9869046901 |
| Fax |
02227749895 |
| Email |
vd.jaikini@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jai Kiran Kini |
| Designation |
Associate Professor Dr. G. D. Pol foundations YMT Ayurvedic Medical College |
| Affiliation |
Dr. G. D. Pol foundations YMT Ayurvedic Medical College |
| Address |
Dr. G. D. Pol foundations YMT Ayurvedic Medical College institutional area sector 4 Kharghar navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9869046901 |
| Fax |
02227749895 |
| Email |
vd.jaikini@gmail.com |
|
|
Source of Monetary or Material Support
|
| charak pharma pvt lt, CALL
DIRECTIONS
SHARE
WEBSITE
SAVE
501/A, BUILDING-2, POONAM CHAMBERS, Dr Annie Besant Rd, Markandeshwar Nagar, Shiv Sagar Estate, Worli, Mumbai, Maharashtra 400018 |
|
|
Primary Sponsor
|
| Name |
charak pharma pvt lt |
| Address |
501/A, BUILDING-2, POONAM CHAMBERS, Dr Annie Besant Rd, Markandeshwar Nagar, Shiv Sagar Estate, Worli, Mumbai, Maharashtra 400018 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 |
| DrJai Kini |
DR G D POL FOUNDATIONS YMT AYURVEDIC MEDICAL COLLEGE |
INSTITUTIONAL AREA SECTOR 4 KHARGHAR NAVI MUMBAI
Raigarh
MAHARASHTRA |
9869046901
02227749895
vd.jaikini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. G. D. Pol Foundation ymt ayurvedic college |
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 |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
participate having sign and symptoms of amlapitta such as amlaudgar and Daha |
|
| ExclusionCriteria |
| Details |
below 20 and above 60 years
known case of intestinal kochs,cholecystitis
addicted alcohol
gastric ulcer ,ibs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief from symptoms of indigestion |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief from symptoms of indigestion |
• Study assessment of all patients will be done at baseline, on 7th day then on 14th as well as on 21st day and at the end of the study i.e. 28th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
28/12/2023 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
yes |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dyspepsia is the commonest ailment found in the present time. Nowadays, due to changing lifestyle people are practicing inappropriate diet and lifestyle that disturbs the entire digestive system. According to Ayurveda, the balance between all three doshas is necessary to keep your digestion optimal. But Pitta dosha plays an important role in the digestion, metabolism, and excretion of food. Amlapitta or dyspepsia is a condition of Annavaha strotas (gastrointestinal system) described in various ayurvedic classics. The cardinal features of Amlapitta are Avipaka (indigestion), Hritkantha Daha (heart and throat burn), and Tikta‑Amlodgara (sour and bitter belching).
CDS syrup is a proprietary formulation by charak pharma, a leading ayurvedic brand for 75 years. It contains 19 ayurvedic herbs that help improve your digestion and relieve dyspepsia. It helps to reduce symptoms of indigestion like bloating, belching, etc. It also has carminative action that helps relieve flatulence or abdominal gases.
|