| CTRI Number |
CTRI/2025/05/087111 [Registered on: 20/05/2025] Trial Registered Prospectively |
| Last Modified On: |
22/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of Amalakyadi churna in Malavastabha (Functional constipation) in children |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED CLINICAL STUDY OF EFFICACY OF AMALAKYADI CHURNA IN THE MANAGEMENT OF MALAVASTAMBHA WITH SPECIAL REFERENCE TO FUNCTIONAL CONSTIPATION 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 Abhishek Pandurang Choure |
| Designation |
PG Scholar |
| Affiliation |
Goverment Ayurved College Nanded |
| Address |
Department of Kaumarbhritya, Government Ayurved College and
Hospital,Nanded, Vazirabad, Nanded. MAHARASHTRA 431601
India
Nanded
MAHARASHTRA
431601
India
Nanded
MAHARASHTRA
431601
India |
| Phone |
9518726017 |
| Fax |
|
| Email |
abhishekchoure817@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhishek Pandurang Choure |
| Designation |
PG Scholar |
| Affiliation |
Goverment Ayurved College Nanded |
| Address |
Department of Kaumarbhritya, Government Ayurved College and
Hospital,Nanded, Vazirabad, Nanded. MAHARASHTRA 431601
India
Nanded
MAHARASHTRA
431601
India
Nanded
MAHARASHTRA
431601
India |
| Phone |
9518726017 |
| Fax |
|
| Email |
abhishekchoure817@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrVijaykumar Uttamrao Gawai |
| Designation |
Head of Department |
| Affiliation |
Goverment Ayurved College ,Nanded |
| Address |
Department of Kaumarbhritya, Government Ayurved College and
Hospital,Nanded, Vazirabad, Nanded. MAHARASHTRA 431601
India
Nanded
MAHARASHTRA
431601
India
Nanded
MAHARASHTRA
431601
India |
| Phone |
9822664004 |
| Fax |
|
| Email |
vijaygawai@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurved
College and Hospital,
Nanded,Vazirabad Nanded,Maharashtra pincode -431601 |
|
|
Primary Sponsor
|
| Name |
Dr Abhishek Pandurang Choure |
| Address |
Department of Kaumarbhritya, Government Ayurved College and
Hospital,Nanded, Vazirabad, Nanded. MAHARASHTRA 431601
India
Nanded
MAHARASHTRA India
431601
|
| 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 Abhishek Pandurang Choure |
Goverment Ayurved College and Hospital Nanded |
Department of
kaumarbhritya,
Government Ayurved
College and Hospital,
Nanded, Vazirabad,
Nanded.
Nanded 431601
MAHARASHTRA
Nanded
MAHARASHTRA |
9518726017
abhishekchoure817@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K590||Constipation. Ayurveda Condition: MALA-APRAVRUTIH (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Lactulose | Syrup Lactulose given orally as per age 2ml/kg/day twice a day for 14 days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Amalakyadi Churna, Reference: Yogratnakara, Route: Oral, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: koshnajala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
Children age between 5 to 14 years Irrespective of cast, sex, socio economic condition and religion.
Patients having symptoms of Functional Constipation as per diagnostic criteria. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Amalakyadi Churna in Malavastambh with special reference to Functional Constipation in children. |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess clinically the efficacy of Analakyadi Churna on consistancy of stool with special reference to Functional Constipation in children |
8days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/06/2025 |
| 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="2"
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 study is randomised controlled clinical study to evaluate the efficacy of Amalakyadi Churna in Malavastambha.Amalakyadi Churna given orally as per requirement to the age group 5years to 14 years twise in a day for 14 days follow up on 0th,8th,14th day this study will be carried out in 2 years of PG course |