| CTRI Number |
CTRI/2025/02/080871 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to evaluate efficacy of Hingwadi churna in management of constipation in children. |
|
Scientific Title of Study
|
To study the assosciation of Prakriti and Vibandha and to determine the efficacy of Hingwadi churna in the management of vibandha w.s.r Functional Constipation in children:A randomized,double blind,parallel group placebo -controlled trial. |
| 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 Devasmita Dash |
| Designation |
Post graduate scholar |
| Affiliation |
|
| Address |
Department of kaumarbhritya, O.P.D NO 5
Government Ayurvedic College and Hospital, Buddhamurti, Kadamkuan,Patna,Bihar
BIHAR
800003
Other |
| Phone |
7978362641 |
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpy Gupta |
| Designation |
Associate Professor (Guide) |
| Affiliation |
Government Ayurvedic College and Hospital,Patna |
| Address |
Department of Kaumarbhritya
Government Ayurvedic College and Hospital, Buddhamurti, Kadamkuan,Patna,Bihar
Patna
BIHAR
800003
India |
| Phone |
7830875453 |
| Fax |
|
| Email |
drguptashilpy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrDevasmita Dash |
| Designation |
Post graduate scholar |
| Affiliation |
|
| Address |
Department of kaumarbhritya O.P.D no - 5
Government Ayurvedic College and Hospital, Buddhamurti, Kadamkuan,Patna,Bihar
Patna
BIHAR
800003
India |
| Phone |
7978362641 |
| Fax |
|
| Email |
devasmitadash.3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College and Hospital,Kadamkuan,Patna
Bihar, PIN - 800003
Country - India |
|
|
Primary Sponsor
|
| Name |
Government Ayurvedic College and Hospital |
| Address |
Department of Kaumarbhritya
Government Ayurvedic College and Hospital,Buddhamurti,Kadamkuan,Patna,800003,Bihar |
| Type of Sponsor |
Government 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 Devasmita Dash |
Government Ayurvedic college and Hospital, Patna |
O.P.D NO -5
Department of Kaumarbhritya
Government Ayurvedic College and Hospital, Buddhamurti,Kadamkuan,800003.
Patna
BIHAR |
7978362641
devasmitadash.3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: VIBANDHA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Placebo powder | Roasted wheat powder given orally 2g in divided dose per day twice daily for 8 weeks | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Hinguwadi churna, Reference: charak chikitsa sthana, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: -ushna jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with a clinical diagnosis of Functional constipation and Fecal incontinence. |
|
| ExclusionCriteria |
| Details |
Subjects who are debilitated or seriously ill, immunocompromised, with suspicion of any organic disease, hypersensitivity to any ingredient in the formulation, or history of surgery. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. For Functional Constipation Screening: Bristol Stool Scale
2. Assessment of Functional Constipation and treatment result: Rome IV Criteria
|
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in sign and symptoms.
|
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| Date of Study Completion (India) |
01/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study will deal with etiopathogenesis and management of Vibandha (constipation) with Ayurveda perspectives. “To study the association of Prakriti and Vibandha and to determine the efficacy of Hingwadi Churna in the management of Vibandha w.s.r. Functional Constipation in Children: A randomized, double blind, parallel group, placebo-controlled trial”. |