| CTRI Number |
CTRI/2023/05/053040 [Registered on: 23/05/2023] Trial Registered Prospectively |
| Last Modified On: |
22/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effect of Nagaradi Kwatha and Yavadi Kwatha in the management of Hyperacidity |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of Nagaradi Kwatha and Yavadi Kwatha in the management of Urdhwaga Amlapitta |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jagruti S Jain |
| Designation |
PG Scholar |
| Affiliation |
Seth Govindji Raoji Ayurved Mahavidyala |
| Address |
Seth Sakharam Nemchand Jain Ayurved Rugnalaya,118/119,Shukrawar peth,Near juni Faujdar Chawadi,Solapur
Madhav Smriti,near old datta mandir,datta chowk,solapur 413007
Solapur
MAHARASHTRA
413002
India |
| Phone |
9604778551 |
| Fax |
|
| Email |
jagruti.jain@pg.sgrayurved.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivek Chandurkar |
| Designation |
HOD Kayachikitsa Department |
| Affiliation |
Seth Govindji Raoji Ayurved Mahavidyala |
| Address |
Seth Sakharam Nemchand Jain Ayurved Rugnalaya,118/119,Shukrawar peth,Near juni Faujdar Chawadi,Solapur
Madhav Smriti,near old datta mandir,datta chowk,solapur 413007
Solapur
MAHARASHTRA
413002
India |
| Phone |
9422788569 |
| Fax |
|
| Email |
vivek.chandurkar@sgrayurved.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jagruti S Jain |
| Designation |
PG Scholar |
| Affiliation |
Seth Govindji Raoji Ayurved Mahavidyala |
| Address |
Seth Sakharam Nemchand Jain Ayurved Rugnalaya,118/119,Shukrawar peth,Near juni Faujdar Chawadi,Solapur
Madhav Smriti,near old datta mandir,datta chowk,solapur 413007
Solapur
MAHARASHTRA
413002
India |
| Phone |
9604778551 |
| Fax |
|
| Email |
jagruti.jain@pg.sgrayurved.edu.in |
|
|
Source of Monetary or Material Support
|
| Seth Sakharam Nemchand Jain Ayurved Rugnalaya,118/119,Shukrawar peth,Near juni Faujdar Chawadi,Solapur |
|
|
Primary Sponsor
|
| Name |
Dr Jagruti S Jain |
| Address |
Seth Sakharam Nemchand Jain Ayurved Rugnalaya,118/119,Shukrawar peth,Near juni Faujdar Chawadi,Solapur |
| Type of Sponsor |
Other [Gov Grant In Aid Ayurved 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 |
| Dr Jagruti S Jain |
Seth Sakharam Nemchand Jain Ayurved Rugnalaya |
Kayachikitsa OPD No.3,2 Seth Sakharam Nemchand Jain Ayurved Rugnalaya,118/119,Shukrawar peth,Near juni Faujdar Chawadi,Solapur
Solapur
MAHARASHTRA |
9604778551
jagruti.jain@pg.sgrayurved.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BORS |
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 | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Nagaradi Kwatha, Reference: Kashyap Samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Yavadi Kwatha, Reference: BHaishjya Ratnavali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Madhu, Trisugandh), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Subjects presenting with classical clinical features of the Amlapitta Chardi (vomiting)
Utklesh (Nausea)
TiktaAmlodgar (Bitter-Sour Blenching)
Hrutkantha Daha ( Retrosternal Burning)
Kara-pada Daha (Burning sensation at hand-legs)
Shirashoola (headache)
Aruchi (Tastelessness)
selected randomly.
2)Subjects between age group 20 to 70 year.
3)Subjects irrespective of age,sex,caste,religion.will be
selected randomly.
|
|
| ExclusionCriteria |
| Details |
1)Subject having known case of gastric ulcers, duodenal ulcers and other chronic co-
morbidities
2) Pregnant and lactating mother.
3)subjects receiving any treatments like NSAIDS, Antibiotic ,Antacids and other long
term medication.
4)Any other addiction like alchohol and tobacco which induces Hyperacidity |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of Yavadi Kwath and Nagaradi Kwath in classical signs and symptoms ( Nausea, burning sensation in chest,etc) of
Urdhwaga Amlapitta. |
45 days with follow up on 15th, 30th, 45th days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To understand indetail Samprapti of Urdhwaga Amlapitta.
2. To understand etiopathology of GERD. |
45 days with follow up on 15th, 30th, 45th days |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/05/2023 |
| 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="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Article not yet published. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In present era due to mordenization of food and lifestyle majority of people suffering from Amlapitta and it is initial causes for many diseases like Peptic ulcers, GERD Gastritis so Nagaradi and Yavadi Kwatha is selected for Samprapti Bhanga and relieve symptoms of Urdhwaga Amlapitta like Chardi (vomiting),Utklesha (Nausea),etc. |