| CTRI Number |
CTRI/2024/08/072577 [Registered on: 16/08/2024] Trial Registered Prospectively |
| Last Modified On: |
11/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical Trial of Herbal Preparation (Laxoherb Kid SyrupR) for Constipation in Children |
|
Scientific Title of Study
|
A Double Blind Randomized Comparative Clinical Trial of Herbal Preparation (Laxoherb Kid SyrupR) with Dietary Regulation and Toilet Training for the Management of 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 |
Achyut Bhattacharyya |
| Designation |
Professor |
| Affiliation |
Professor, Department of Kaumarbhritya |
| Address |
OPD Room No. 11, Department of Kaumarbhritya
J. B. Roy State Ayurvedic Medical College and Hospital, Kolkata 700004
Kolkata
WEST BENGAL
700004
India |
| Phone |
9127777715 |
| Fax |
|
| Email |
achyut.bhattacharyya@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Achyut Bhattacharyya |
| Designation |
Professor |
| Affiliation |
Professor, Department of Kaumarbhritya |
| Address |
OPD Room No. 11, Department of Kaumarbhritya
J. B. Roy State Ayurvedic Medical College and Hospital, Kolkata 700004
Kolkata
WEST BENGAL
700004
India |
| Phone |
9127777715 |
| Fax |
|
| Email |
achyut.bhattacharyya@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Achyut Bhattacharyya |
| Designation |
Professor |
| Affiliation |
Professor, Department of Kaumarbhritya |
| Address |
OPD Room No. 11, Department of Kaumarbhritya
J. B. Roy State Ayurvedic Medical College and Hospital, Kolkata 700004
Kolkata
WEST BENGAL
700004
India |
| Phone |
9127777715 |
| Fax |
|
| Email |
achyut.bhattacharyya@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Jupiter Pharmaceuticals Limited, Synthesis Business Park, 9C(A, Action Area II, Rajarhat, Newtown, Kolkata, PIN 700157 |
|
|
Primary Sponsor
|
| Name |
Jupiter Pharmaceuticals Limited |
| Address |
Synthesis Business Park, 9C(A), 9th Floor, Action Area II, New Town, Kolkata 700157 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Achyut Bhattacharyya |
J. B. Roy State Ayurvedic Medical College and Hospital, Kolkata |
OPD Room No. 11, Department of Kayachikitsa
J. B. Roy State Ayurvedic Medical College and Hospital,
170-172 Raja Dinendra Street, Kolkata
PIN-700004
Kolkata
WEST BENGAL |
9123777715
achyut.bhattacharyya@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, J. B. Roy State Ayurvedic Medical College and Hospital |
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 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Laxoherb Kid Syrup , Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 10(ml), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Sukoshna Jala), Additional Information: (2) Age 9-16 years, thrice daily for 15 days | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Laxoherb Kid Syrup , Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Sukoshna Jala), Additional Information: (1) Age 2-8 years, 5 ml orally, twice daily for 15 days | | 3 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Placebo syrup, Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Sukoshna Jala-), Additional Information: (3) Age 2-8 years, 5 ml orally twice daily for 15 days | | 4 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Placebo Syrup, Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 10(ml), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Sukoshna Jala), Additional Information: (4) Age 9-16 years, 10 ml orally, thrice daily for 15 days |
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
The children of either gender between the age group of 02-16 years fulfilling the diagnostic criteria of functional constipation, whose parents are willing to give consent, will be registered for the clinical study |
|
| ExclusionCriteria |
| Details |
Children having constipation secondary to any of the other diseases like hypothyroidism, hirschprung’s disease and structural anomalies of anal canal will be excluded from the trial based on clinical presentations |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The effect of Laxoherb Kid Syrup in the management of Vibandha (Functional constipation) in children |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare the effect of trial drugs with respect to placebo drug, dietary regulation and toilet training |
15 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
02/09/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Constipation in children is defined as a delay or difficulty in defecation resent for two or more weeks. According to Ayurveda “Vibandha†is among the commonest clinical conditions in children with difficulty defecating, hard stools, and infrequent bowel movements. The current trial is proposed to study the effect of Laxoherb Kid Syrup by using specific parameters for Vibandha w.s.r. to functional constipation. The objective of the present study is to evaluate the effect of Laxoherb Kid Syrup in the management of Vibandha (Functional constipation) in children. The children of either gender between the age group of 02-16 years fulfilling the diagnostic criteria of functional constipation, whose parents are willing to give consent, will be registered for the clinical study. The test drug, Laxoherb Kid Syrup will be given in two groups (a) age 2-8 yrs. at the dose of 5 ml twice daily orally for 15 days and (b) age 9-16 yrs. at the dose of 10 ml thrice daily orally for 15 days. The placebo will be given at the same dose without active ingredients. The assessment will be done following the ROME III criteria and Bristol criteria for functional constipation depending upon the age of the child at day 15. The safety blood profile will also be checked. The data collected before and after the intervention within the group and between the groups will be recorded and evaluated using non-parametric statistical methods (Wilcoxon signed rank test, Mann Whitney test and Chi-square test which will be applicable. |