| CTRI Number |
CTRI/2025/02/080844 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
08/02/2025 |
| 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 role of Lodhradi Churna and Balchaturbhadra Churna in children Diarrhoea |
|
Scientific Title of Study
|
A Comparative Clinical Study on Lodhradi Churna and Balchaturbhadra Churna in the management of Balatisara 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 Dolly Shukla |
| Designation |
MD Scholar |
| Affiliation |
State Ayurvedic College and Hospital, Lucknow |
| Address |
P. G. Dept. Of Kaumarabhritya OPD No.1 State Ayurvedic College and hospital, Lucknow
Lucknow
226003
UTTAR PRADESH
India
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8574857594 |
| Fax |
|
| Email |
shukla0791@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Narayan Gupta |
| Designation |
Reader |
| Affiliation |
State Ayurvedic College and Hospital, Lucknow |
| Address |
P. G. Dept. Of Kaumarabhritya OPD No.1 State Ayurvedic College and hospital, Lucknow
Lucknow
226003
UTTAR PRADESH
India
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9415447523 |
| Fax |
|
| Email |
mngupta75@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahesh Narayan Gupta |
| Designation |
Reader |
| Affiliation |
State Ayurvedic College and Hospital, Lucknow |
| Address |
P. G. Dept. Of Kaumarabhritya OPD No.1 State Ayurvedic College and hospital, Lucknow
Lucknow
226003
UTTAR PRADESH
India
UTTAR PRADESH
226003
India |
| Phone |
9415447523 |
| Fax |
|
| Email |
mngupta75@yahoo.com |
|
|
Source of Monetary or Material Support
|
| State Ayurvedic College and Hospital,Turiyaganj,Tulsidas Marg, Lucknow Uttar Pradesh Pincode 226003 |
|
|
Primary Sponsor
|
| Name |
State Ayurvedic College and Hospital Lucknow |
| Address |
Tulsidas Marg, old Haiderganj, Lucknow 226003 Uttar Pradesh , India |
| 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 Dolly Shukla |
State Ayurvedic College and Hospital, Lucknow |
P. G. Dept. Of Kaumarabhritya OPD NO. 1 State Ayurvedic College and Hospital, Tulsidas Marg,Tudiyaganj, Lucknow 226003 Uttar Pradesh ,
Lucknow
UTTAR PRADESH |
8574857594
shukla0791@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Institutional Ethics Committee State Ayurvedic College and Hospital Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K909||Intestinal malabsorption, unspecified. Ayurveda Condition: ATISARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Lodhradi churna, Reference: Yogratnakar balrog chikitsa , Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 15(ml), Frequency: tds, Bhaishajya Kal: Antarabhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bal chaturbhadra churna, Reference: Bhaishajya ratnawali, bal rogadhikar 71/38, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 15(ml), Frequency: tds, Bhaishajya Kal: Antarabhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients having age between 2 year to 10 years.
2 Patients lying under diagnostic criteria.
3 Patients having mild degree of dehydration.
4 Patients/parents who are willing to participate in trial.
5 Patients having loose and watery stool within 7 days.
|
|
| ExclusionCriteria |
| Details |
1 Patient suffering from moderate to severe dehydration.
2 Severe dysentery and high grade fever.
3 Persistent vomiting.
4 Any serious life-threatening disease.
5 Associated with severe systemic disease.
6 Severe case of diarrhea.
7 Patients having persistent loose and watery stool more than 7 days.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in condition of children.
Improvement in frequency/consistency of stool.
Improvement in abdominal pain. |
After 15 days of complete clinical trial. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Bal chaturbhadra churna and Lodhradi churna |
After completing the 15the day of trial. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
21/02/2025 |
| 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="0"
Months="0"
Days="15" |
|
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 this research evaluate the efficacy of Lodhradi Churna and Balchaturbhadra Churna in children diarrhoea. Trial drug will be given in 2 group. This research is double blind randomised parallel group comparative study. Maximum 40 subjects will be taken aged between 2 to 10 years. In first group Lodhradi syrup will be given and in second group Balchaturbhadra syrup will be given orally. The total duration of trial is 15 days and follow up will be done at 3rd, 5th, 7th, and 15th day. |