| CTRI Number |
CTRI/2024/05/067115 [Registered on: 09/05/2024] Trial Registered Prospectively |
| Last Modified On: |
25/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Ash gourd consumption orally and Kunjal Kriya in reducing the symptoms of Acidity. |
|
Scientific Title of Study
|
“A Comparative study to evaluate the efficacy of Vamana Dhauti and
Kushmanda(Benincasa hispida) Rasa in Amlapitta- A Randomized Clinical Trial†|
| 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 AMRUTHA JAYAN |
| Designation |
P.G Scholar |
| Affiliation |
Ch. Brahm Prakash Ayurved Charak Sansthan |
| Address |
Room No.222 PG Department of Swasthavritta,2nd Floor Ch. Brahm Prakash Ayurved Charak Sansthan,Khera Dabar,Najafgarh South West Delhi
South West
DELHI
110073
India |
| Phone |
6282470300 |
| Fax |
|
| Email |
dramruthajayan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr JAI SINGH YADAV |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Ch.Brahm Prakash Ayurved Charak Sansthan |
| Address |
Room.No.230 PG Department of Swasthavritta,2nd Floor Ch.Brahm Prakash Ayurved Charak Sansthan ,
Khera Dabar, Najafgarh, South West Delhi
South West
DELHI
110073
India |
| Phone |
7568730726 |
| Fax |
|
| Email |
dr_jaisinghyadav@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr JAI SINGH YADAV |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Ch.Brahm Prakash Ayurved Charak Sansthan |
| Address |
Room.No.230 PG Department of Swasthavritta,2nd Floor Ch.Brahm Prakash Ayurved Charak Sansthan ,
Khera Dabar, Najafgarh, South West Delhi
South West
DELHI
110073
India |
| Phone |
7568730726 |
| Fax |
|
| Email |
dr_jaisinghyadav@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Ch.Brahm Prakash Ayurved Charak Sansthan,Khera Dabar,Najafgarh,SouthWest Delhi,110073 |
|
|
Primary Sponsor
|
| Name |
Ch.Brahm Prakash Ayurved Charak Sansthan |
| Address |
Ch.Brahm Prakash Ayurveda Charak
Sansthan,Khera Dabar,Najafgarh,South West Delhi,Pin-110073 |
| Type of Sponsor |
Government 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 |
| DrAMRUTHA JAYAN |
Ch.Brahm Prakash Ayurved Charak Sansthan |
Room No. 222,Second Floor,PG Department of Swasthavritta and Yoga,Ch. Brahm Prakash Ayurved Charak Sansthan,Khera Dabar,Najafgarh,Southwest Delhi
South West
DELHI |
6282470300
dramruthajayan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Ch. Brahm Prakash Ayurveda Charak Sansthan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K20-K31||Diseases of esophagus, stomach and duodenum. Ayurveda Condition: AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | vamana dhauti | (Procedure Reference: Gheranda Samhita, Procedure details: Patient will be advised to sit in kagaasana and to drink 3-4 glass (approx. 2 litre) of lukewarm water added with saindhava salt.
Subject is made to drink water continuously, uninterruptedly until the stomach is full and can no more take a single drop of water further, then given one more glass. This may be a little difficult but it is essential to fill the stomach as fully as possible. Under these circumstances, the urge to throw out the water from the stomach hardly needs to be stimulated, it)
| | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kushmanda Rasa, Reference: Bhavaprakasha, Route: Oral, Dosage Form: Swaras/ Juice, Dose: 150(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Classical symptoms of Amlapitta.
2.Patients willing and able to carry out treatment for 21 days.
3.Patients will be registered with duly signed informed consent prior to the trial.
|
|
| ExclusionCriteria |
| Details |
1.Patients with diagnosed cases of gastric, peptic and duodenal ulcers.
2.Patients with any GIT, abdominal complications and chronic illness.
3.Patients with diagnosed cases of any systemic disorder.
4.Pregnant and lactating women.
5.Patients suffering from raised intracranial pressure, hernia, diabetes with eye problems, heart diseases
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Vamana Dhauti and Kushmanda Rasa are expected to allievate Amlapitta |
1st Assessment on Day 1
2nd Assessment on Day 11
3rd Assessment on Day 21 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Subjective Parameters |
1st Assessment on Day 1
2nd Assessment on Day 11
3rd Assessment on Day 21 |
|
|
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 3 |
|
Date of First Enrollment (India)
|
25/05/2024 |
| 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="0"
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
|
In this randomized Clinical Trial,we are going to compare the efficacy of Kushmanda Rasa and Vamana Dhauti in the patients of Amlapitta.With a total sample size of 60 patients,the study focuses on reduction in the symptoms of Amlapitta as the primary measure by dividing the total participants into two groups,with 30 in each of them.One group will be given Kushmanda Rasa and other will be given Vamana Dhauti.Assessment will be recorded on Day 1 (before treatment),Day 11,Day 21.The trial will be conducted in Ch. Brahm Prakash Ayurved Charak Sansthan, Khera Dabar,Delhi. |