| CTRI Number |
CTRI/2024/01/061317 [Registered on: 10/01/2024] Trial Registered Prospectively |
| Last Modified On: |
30/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study evaluate the effect of ayurvedic formulation in constipation |
|
Scientific Title of Study
|
RANDOMIZED CONTROLLED CLINICAL STUDY ON EFFICACY OF ARAGVADHA SYRUP IN MANAGEMENT OF MALAVIBANDH IN CHILDREN |
| 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 Kalyani Prataprao Aher |
| Designation |
PhD Scholar |
| Affiliation |
Chhatrapati Shahu Maharaj Education Institute Ayurved College |
| Address |
Department of Kaumarbhritya Chhatrapati Shahu Maharaj Education Institute Ayurved College Paithan Road Kanchanwadi
Aurangabad
MAHARASHTRA
431002
India |
| Phone |
9421400842 |
| Fax |
|
| Email |
drkalyaniaher@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karuna Ratnaparkhi |
| Designation |
Prof. and HOD |
| Affiliation |
Chhatrapati Shahu Maharaj Education Institute Ayurved College |
| Address |
Department of Kaumarbhritya Chhatrapati Shahu Maharaj Education Institute Ayurved College Paithan Road Kanchanwadi
Aurangabad
MAHARASHTRA
431002
India |
| Phone |
9421771722 |
| Fax |
|
| Email |
karunaratnaparkhi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Karuna Ratnaparkhi |
| Designation |
Prof. and HOD |
| Affiliation |
Chhatrapati Shahu Maharaj Education Institute Ayurved College |
| Address |
Department of Kaumarbhritya Chhatrapati Shahu Maharaj Education Institute Ayurved College Paithan Road Kanchanwadi
MAHARASHTRA
431002
India |
| Phone |
9421771722 |
| Fax |
|
| Email |
karunaratnaparkhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chhatrapati Shahu Maharaj Education Institude Ayurved College Paithan Road Kanchanwadi Aurangabad. |
|
|
Primary Sponsor
|
| Name |
CSMSS Ayurved College And CSMSS Ayurved Hospital and Research Center. |
| Address |
Paithan Road Kanchanwadi Aurangabad Maharashtra 431002 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Kalyani Prataprao Aher |
CSMSS Ayurved College And CSMSS Ayurved Hospital and Research Center. |
OPD and IPD department of kaumarbhritya Paithan Road Kanchanwadi
Aurangabad
MAHARASHTRA |
9421400842
drkalyaniaher@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee Chhatrapati Shahu Maharaj Shikshan Sansthas Ayurved Mahavidyalaya & Rugnalaya, Kanchanwadi, Aurangabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K590||Constipation. Ayurveda Condition: VIBANDHA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: aragvadha syrup, Reference: charak kalpasthana 8, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 0.66(ml), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | lactulose syrup | oral, 1-3 ml/kg/day, 7 days with water, hs |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
patient having age between 3 to 10 year
children fulfilling the ROME-III CRITERIA 10. |
|
| ExclusionCriteria |
| Details |
Psychosomatic disorder
Acute systemic/ Febrile illness
drug induced constipation
obstructive pathology which intervence with treatment.
chronic and reccurent phase of constipation. |
|
|
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 |
| frequency and consistancy of faeces, severity of pain |
0,3,7,15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| frequency and consistancy of faeces, severity of pain |
15 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/01/2024 |
| 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="3"
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 modern medicine treatment of constipation is mainly Laxatives. The most common and important side effect of laxative is that it leads to dependency. It is important to focus on traditional and Conventional treatment described in Ayurveda Samhita.
Aragvadha has mruduvirechak property and commonly used in malavibandha, it does not have side effect and easily available as well as cost effective. It does not lead to dependency. And syrup is palatable so syrup form is used. So, to study the efficiency of the drugs the topic is selected. |