| CTRI Number |
CTRI/2019/01/016977 [Registered on: 08/01/2019] Trial Registered Prospectively |
| Last Modified On: |
07/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [TREATMENT] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF PATOLADI KWATHA (Herbal decoction) AND PAARIBHADRADI KWATHA (Herbal decoction) IN THE MANAGEMENT OF AMLAPITTA (Hyper Acidity) |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF PATOLADI KWATHA AND PAARIBHADRADI KWATHA IN THE MANAGEMENT OF 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 Nagalakshmi A S |
| Designation |
PG Scholar |
| Affiliation |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre |
| Address |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre
No 10 Pipeline Road Vijayanagar Bengaluru 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
8277336635 |
| Fax |
|
| Email |
nagalakshmias23492@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajashekhar CV |
| Designation |
Professor |
| Affiliation |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre |
| Address |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre
No 10 Pipeline Road Vijayanagar Bengaluru 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
8867212844 |
| Fax |
|
| Email |
drrajhere@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nagalakshmi A S |
| Designation |
PG Scholar |
| Affiliation |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre |
| Address |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre
No 10 Pipeline Road Vijayanagar Bengaluru 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
8277336635 |
| Fax |
|
| Email |
nagalakshmias23492@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR NAGALAKSHMI A S |
| Address |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre
No 10 Pipeline Road Vijayanagar Bengaluru 560104 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NOT APPLICABLE |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajashekhar C V |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre
No 10 Pipeline Road Vijayanagar Bengaluru 560104
Bangalore
KARNATAKA |
8867212844
drrajhere@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SKAMCH & RC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K297||Gastritis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
PAARIBHADRADI KWATHA |
PAARIBHADRADI KWATHA
24ML TWICE DAILY BEFORE FOOD
FOR 14DAYS
|
| Intervention |
PATOLADI KWATHA |
PATOLADI KWATHA
24ML TWICE DAILY BEFORE FOOD
FOR 14DAYS
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients within the age group 20-70 years of either sex.
Patients with samanya lakshanas of Amlapitta
|
|
| ExclusionCriteria |
| Details |
Pregnant women and lactating mother .
Complications which will intervene the course of treatment.
Patients suffering from other systemic diseases which interfere with the course of treatment
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| EFFICACY OF INTERVENTION OVER SUBJECTIVE CRETIRIA OF AMLAPITTA. |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NOT APPLICABLE |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
10/01/2019 |
| 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="3"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT YET PUBLISHED |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
AMLAPITTA IS ONE AMONG THE ANNAVAHA SROTO DUSHTI VIKARAS.THE LAKSANAS OF AMLAPITTA CAN BE CORRELATED WITH
THE SYMPTOMS OF HYPERACIDITY. HYPERACIDITY AFFECTS ABOUT 20% OF THE ADULTS WHO
REPORT WEAKLY EPISODES OF HEARTBURN. THE PREVELANCE OF HEARTBURN AND OTHER ACID
REFLEX DISEASE ROSE NEARLY 50% OVER THE LAST DECADE. PATOLADI KWATHA WHICH IS
MENTIONED IN CHAKRADATTA, AMLAPITTA CHIKITSA HAVING THE INGREDIENTS PATOLA,
SHUNTI AND DHANYAKA HAS KAPHA PITTA HARA PROPERTY. PAARIBHADRADI KWATHA
MENTIONED IN HARITHA SAMHITHA FOR AMLAPITTA CHIKITSA,WHICH HAS THE INGREDIENTS
LIKE PAARIBHADRA DALA AND AMALAKI PHALA, PAARIBHADRA DALA WHICH HAS
PITTAROGAGHNA PROPERTY AND AMALAKI PHALA IS MADURA VIPAKA,WHICH IS BENEFICIAL
IN PITTAJA VIKARAS. THIS STUDY IS DOUBLE ARM OPEN LABEL COMPARATIVE CLINICAL
STUDY COMPARING THE EFFICACY OF PATOLADI KWATHA 24ML TWICE DAILY FOR 14 DAYS
AND PAARIBHADRADI KWATHA 24ML TWICE DAILY FOR 14 DAYS FOR 20 PATIENTS IN EACH
GROUP WHICH INCULDES THE CLASSICAL SIGN & SYMPTOMS OF AMLAPITTA.THIS STUDY
WILL BE CONDUCTED IN SRI KALABYRAVESHWARA SWAMY AYURVEDIC MEDICAL COLLEGE
HOSPITAL AND RESEARCH CENTER, BENGALURU,KARNATAKA |