| CTRI Number |
CTRI/2024/07/070382 [Registered on: 10/07/2024] Trial Registered Prospectively |
| Last Modified On: |
05/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate the effectiveness of simhayadi kwatha and patoladipanchanga kwatha in the treatment of amlapitta (Gastro esophageal reflex disease) |
|
Scientific Title of Study
|
A randomized comparative clinical study to evaluate the efficacy of simhasyadi kwatha and patoladipanchanga kwatha in management of 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 |
Dr Vijayalakshmi Teggi |
| Designation |
PG scholar |
| Affiliation |
ALN Rao memorial Ayurvedic medical college |
| Address |
Department of kayachikitsa 1st floor, ALN Rao Memorial Ayurvedic Medical College koppa.
chikkamagalore
Karnataka
india
Chikmagalur
KARNATAKA
577126
India |
| Phone |
7022640368 |
| Fax |
|
| Email |
drteggi8105@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Keshava D V |
| Designation |
Professor |
| Affiliation |
ALN RAO Memorial ayurvedic medical college koppa |
| Address |
Department of kayachikitsa 1st floor, ALN Rao Memorial Ayurvedic Medical College koppa.
chikkamagalore
Karnataka
india
Chikmagalur
KARNATAKA
577126
India |
| Phone |
9880031849 |
| Fax |
|
| Email |
keshavamdkc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr vijayalakshmi Teggi |
| Designation |
PG schloar |
| Affiliation |
ALN RAO memorial ayurvedic medical college koppa |
| Address |
Department of kayachikitsa 1st floor, ALN Rao Memorial Ayurvedic Medical College koppa.
chikkamagalore
Karnataka
india
Chikmagalur
KARNATAKA
577126
India |
| Phone |
7022640368 |
| Fax |
|
| Email |
drteggi8105@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of kayachikitsa 1st floor, ALN Rao Memorial Ayurvedic Medical College koppa.
chikkamagalore
Karnataka
india |
|
|
Primary Sponsor
|
| Name |
Dr Vijayalakshmi Teggi |
| Address |
Department of kayachikitsa 1st floor, ALN Rao Memorial Ayurvedic Medical College koppa.
chikkamagalore
Karnataka
india |
| Type of Sponsor |
Private 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 |
| Dr Vijayalakshmi Teggi |
ALN RAO memorial ayurvedic medical college and hospital |
Kayachikitsa OPD room no 1,ALN Rao memorial ayurvedic hospital,kachakal raod,koppa,chikkamagalore
KARNATAKA
Chikmagalur
KARNATAKA |
7022640368
drteggi8105@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ALN Rao Memorial Ayurvedic Medical 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 | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Patoladi panchanga kwatha, Reference: chakradatta, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: madhu), Additional Information: kashaya will be administered with 10ml of madhu | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Simhasyadi kwatha, Reference: chakradatta, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: madhu), Additional Information: kashaya will be administered with 10ml of madhu |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject of either sex.
2. Subject within the age group 18-60 yrs.
3. Subjects with clinical features of Amlapitta such as Avipaka, Klama, Uthklesha, Tikta Amlodgara, Gourava, Hruthkanta daha, and Aruchi will be included.
4. Subjects with controlled systemic disorder such as DM, HTN, etc will be included.
5. Subjects who are willing to give written consents for the study. |
|
| ExclusionCriteria |
| Details |
1. Pregnant and Lactating women
2. Subjects with uncontrolled systemic disorder such as Diabetes mellitus, Hypertension, etc
3. Subject diagnosed with Gastro- intestinal disorders like peptic ulcer, pancreatic and hepatic disorders.
4. Subjects with history of haematemesis, malena and other systemic disorders that may interfere with the clinical trial. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effect of treatment will be assessed on the basis of changes found in the gradation of the both individual and overall parameters according to their severity before, during and after treatment.
SUBJECTIVE PARAMETERS
Avipaka (digestion)
Klama (tiredness)
Uthklesha (nausea)
Tikta amlodgara ( sour and bitter belching)
Gourava (heaviness of body)
Hruthkanta daha (burning sensation of throat )
Aruchi (anorexia) |
30 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NOT APPLICABLE |
NOT APLLICABLE |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
16/07/2024 |
| 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
|
This is a randomized comparative clinical study to evaluate the effect of two groups of kwatha in management of symptoms of amlapitta for 30 days this study comprise of two groups of 30 patients selected as per inclusion and exclusion citeria study will be Conducted in ALN Rao memorial ayurvedic hospitals in koppa and guard hullow places, koppa taluk chikamagluru distric 677126 kamalaka,india primary aim of the study is to evaluate the efficacy of gatuled panchange kwitha with serbased seetha which weit be most effective in managing symptoms of amlapitta in 30 days |