| CTRI Number |
CTRI/2024/10/075604 [Registered on: 22/10/2024] Trial Registered Prospectively |
| Last Modified On: |
09/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical study to see the effect of vasadi dashang ghan vati in 60 patients having urdhwag amlapitta (Gastro oesophagial Reflux Disease) |
|
Scientific Title of Study
|
An open randomized controlled clinical study of efficacy of vasadi dashang ghan vati in the management of urdhwag 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 |
Vaishali Shivlal Deshmukh |
| Designation |
Post Graduate Student |
| Affiliation |
APMs Ayurved Mahavidyalaya Sion Mumbai |
| Address |
Department of kaychikitsa fourth floor APMs Ayurved Mahavidyalaya Sion Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9158783563 |
| Fax |
|
| Email |
deshmukhvs2901@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemant Paradkar |
| Designation |
Associate professor |
| Affiliation |
APMs Ayurved Mahavidyalaya Sion Mumbai |
| Address |
Department of kayachikitsa APMs Ayurved Mahavidyalaya Sion Near Sion Railway Station Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9987519315 |
| Fax |
|
| Email |
hemant.paradkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemant Paradkar |
| Designation |
Associate professor |
| Affiliation |
APMs Ayurved Mahavidyalaya Sion Mumbai |
| Address |
Department of kayachikitsa APMs Ayurved Mahavidyalaya Sion Near Sion Railway Station Mumbai
MAHARASHTRA
400022
India |
| Phone |
9987519315 |
| Fax |
|
| Email |
hemant.paradkar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vaishali Shivlal Deshmukh |
| Address |
APMs Ayurved Mahavidyalay Sion Near Sion Railway Station sion Mumbai |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Vaishali Shivlal Deshmukh |
APMs Seth R V Ayurvedic Hospital |
Department of kaychikitsa Room No 9 Near Sion Railway Station Sion East Mumbai 400022.
Mumbai
MAHARASHTRA |
9158783563
deshmukhvs2901@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| APMs Ayurved Mahavidyalaya Sion IEC |
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: URDHVAGATA-AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vasadi dashang kwath ghan vati, Reference: chakradatta amlpittachikitsa adhyay shlok no.11, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -honey), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | cap. omeprazole | Cap.Omeprazole 20 mg OD before meal for 21 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.All sex
2.Age 18-80 years
3.Patients presenting with Lakshanas of amlapitta |
|
| ExclusionCriteria |
| Details |
1.Pregnant and lactating women.
2.Participant those are k/c/o chronic alcohol addiction
3.Not willing for trial or non-cooperative patients
4.Patients those are k/c/o HIV, HbsAg
5.Patients who are on steroid, non-steroid anti-inflammatory drugs. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in symptoms of urdhwag amlapitta |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Avipak (Indigestion)
2. Klama (tiredness)
3. Utklesha (Nausea)
4. Tikta-mlodgar (sour and bitter belching).
5. Gaurav (Heaviness in the body)
6. Hrit-Kantha daha (Burning sensation at epigastrium and chest)
7. Aruchi (Anorexia) |
21 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
01/11/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Gastro oesophageal reflux Disease (GERD) is typically managed using medications like H2 blockers and Proton Pump Inhibitors (PPI). However, these drugs primarily offer symptomatic relief and can lead to patient dependency. Short-term use of PPI may result in side effects such as headaches, rashes, dizziness, and various gastrointestinal issues like nausea, abdominal pain, flatulence, constipation, and diarrhoea and PPI long term use causes side effects like iron deficiency anaemia. Therefore, there is a growing need for an alternative drug that effectively manages Amlapitta (GERD) with fewer side effects. Currently, Ayurveda is gaining popularity because many Ayurveda medicines are herbal preparations with minimal or no harmful side effects. This has sparked interest in exploring Ayurveda alternatives that can alleviate the signs and symptoms of Urdhwag Amlapitta (GERD) in comparison to the modern drug Omeprazole. Out of many medicines described in samhita for the treatment of Urdhwag amlapitta vasadi dashang kwath has been stated to be useful in Amlapitta . So this research is to study vasadi dashang kwatha in the form of Ghan vati .Ghan vati has less particle size as compare to kwatha kalpana, also easy handling makes it convenient for patient. Also, comparing efficacy of ghan vati in urdhwag Amlapitta with modern drug Omeprazole. As we know modern drug has its own side effects so there is need for its alternative in ayurveda. |