| CTRI Number |
CTRI/2024/03/064297 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
17/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the comparative effect of pathyadi churna and avipattikar churna in the management of amlapitta. |
|
Scientific Title of Study
|
A randomized parallel arm comparative clinical study to evaluate the efficacy of pathyadi churna and avipattikar churna in the 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 Samarth Kasliwal |
| Designation |
PG SCHOLAR |
| Affiliation |
Seth Govindji Raoji Ayurved Mahavidhyalaya |
| Address |
OPD no 2,3,10, kayachikitsa department, Seth Sakharam Nemchand Jain Ayurveda Rugnalaya, 118/119 shukrawar peth, near juni faujdar chawdi, solapur,
MAHARASHTRA
413002
India
Solapur
MAHARASHTRA
413002
India |
| Phone |
9689824232 |
| Fax |
|
| Email |
samarth.kasliwal@pg.sgrayurved.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Channamma Hiremath |
| Designation |
Associate Professor, kayachikitsa department |
| Affiliation |
Seth Govindji Raoji Ayurved Mahavidhyalaya |
| Address |
OPD no 2,3, kayachikitsa department, Seth Sakharam Nemchand Jain Ayurveda Rugnalaya, 118/119 shukrawar peth, near juni faujdar chawdi, solapur,
MAHARASHTRA
413002
India
Solapur
MAHARASHTRA
413002
India |
| Phone |
7756977095 |
| Fax |
|
| Email |
channamma.hiremath@sgrayurved.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Samarth Kasliwal |
| Designation |
PG SCHOLAR |
| Affiliation |
Seth Govindji Raoji Ayurved Mahavidhyalaya |
| Address |
OPD no 2,3,10 kayachikitsa department, Seth Sakharam Nemchand Jain Ayurveda Rugnalaya, 118/119 shukrawar peth, near juni faujdar chawdi, solapur,
MAHARASHTRA
413002
India
Solapur
MAHARASHTRA
413002
India |
| Phone |
9689824232 |
| Fax |
|
| Email |
samarth.kasliwal@pg.sgrayurved.edu.in |
|
|
Source of Monetary or Material Support
|
| Seth Sakharam Nemchand Jain Ayurveda Rugnalaya, 118/119 shukrawar peth, near juni faujdar chawdi, solapur,
MAHARASHTRA
413002
India |
|
|
Primary Sponsor
|
| Name |
Dr Samarth Kasliwal |
| Address |
Seth Sakharam Nemchand Jain Ayurveda Rugnalaya, 118/119 shukrawar peth, near juni faujdar chawdi, solapur,
MAHARASHTRA
413002
India |
| 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 |
| Dr Samarth Kasliwal |
Seth Sakharam Nemchand Jain C chawdi, solapur, MAHARASHTRA 413002 India |
OPD 3,2, kayachikitsa department, Seth Sakharam Nemchand Jain Ayurveda Rugnalaya, 118/119 shukrawar peth, near juni faujdar chawdi, solapur,
MAHARASHTRA
413002
India
Solapur
MAHARASHTRA |
9689824232
samarth.kasliwal@pg.sgrayurved.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Seth Govindji Raoji ayurved Mahavidyalaya ethical committee |
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: Avipattikar churna, Reference: Bhaishajya ratnavali 53/25-29, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -sheetal jal), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pathyadi churna , Reference: chakradatta amlapittaharyog 52/13, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -guda), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants between Age group -18-60 years
2) Participants irrespective of age,sex,caste,religion
3) Participants presenting with primary classical features of the
Amlapitta with 1 or more secondary features will be selected |
|
| ExclusionCriteria |
| Details |
1) Pregnant & lactating mothers.
2) Participants on NSAIDs.
3) Participants on long term steroids (for more than 6 months)
4) Known case of Intestinal TB, CA Stomach.
5) Known case of DM, Kidney diseases, Hepatobiliary
diseases and Ulcerative colitis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the effect of pathyadi churna in the
management of amlapitta. |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To study Safety of pathyadi churna & avipattikar churna in the management of amlapitta.
2)To understand in detail Samprapti of Amlapitta |
21 days |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
25/03/2024 |
| 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
|
Amlapitta is a most remarkable Problem in the society in modern era. The
use of an antacid has symptomatic relief only ,but is not reliable for long term
medication.Madhavkara stated that, Amlapitta can be easily managed in early stage.
In chronic conditions of Amlapitta, treatment should be given for very long time.
And for this long-term treatment, there is need for herbal medicine to use.Pathyadi Churna and Avipattikar Churna are drugs having Amlapittahar
property and Snigdha, Guru Gunas which is mentioned in Chakradutta and
Bhaisajya Ratnavali as Amlapittahar yog. Churna Kalpna is a modified form of
Kalka Kalpana and can be easily prescribed, Hence taking into consideration of its
severity a combination of Haritaki , Bhringraj and Guda has taken to prove its
efficacy for the satisfactory management of Amlapitta.Hence this topic is selected to study the efficacy of pathyadi churna and avipattikar churna in the management of amlapitta.the studywill be conducted for 21 days ,having follow up on 7th ,14th and 21st day.pathyadi churna and avipattikar churna will be given for 21 days before food with water.Before and After treatment assessment will be done with help of symptom relief. |