| CTRI Number |
CTRI/2024/09/073743 [Registered on: 10/09/2024] Trial Registered Prospectively |
| Last Modified On: |
05/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between Balachaturbhdra churna and Balachaturbhdra avaleha in children in coughing |
|
Scientific Title of Study
|
A comparative pharmaceutical analytical study of balachaturbhdra churna with its another dosage form i.e.balachaturbhdra avaleha with special reference to kasa 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 sangeeta pal |
| Designation |
MD scholar |
| Affiliation |
Government Ayurvedic College and Hospital, chaukaghat, Varanasi |
| Address |
Department of Rasshasrtra and Bhaishajya kalpana
Government Ayurvedic College and Hospital, varanasi
Uttar Pradesh 212011
Varanasi
Varanasi
UTTAR PRADESH
212011
India |
| Phone |
9005836579 |
| Fax |
|
| Email |
sangeeta.sukham18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ProfSanjay Kumar pandey |
| Designation |
Professor head of department rsbk |
| Affiliation |
Government Ayurvedic College and Hospital chaukaghat Varanasi |
| Address |
Department of Rasshasrtra and Bhaishajya kalpana, Government Ayurvedic College and Hospital chaukaghat Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
919417077401 |
| Fax |
|
| Email |
dr.spandey2007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ruchi Tiwari |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurvedic College and Hospital chaukaghat Varanasi |
| Address |
Department of kaumarbhritya and balroga government Ayurvedic College and Hospital chaukaghat Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
919453642440 |
| Fax |
|
| Email |
drruchitiwari408@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College and Hospital, chaukaghat, Varanasi .Uttar Pradesh, india,pin code-221001
|
|
|
Primary Sponsor
|
| Name |
Government Ayurvedic College and Hospital chaukaghat Varanasi |
| Address |
Government Ayurvedic College and Hospital chaukaghat Varanasi Uttar Pradesh india pin code 221001 |
| 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 |
| SANGEETA PAL |
GOVERNMENT AYURVEDIC COLLEGE AND HOSPITAL |
OPD 5 and opd 9
Varanasi
UTTAR PRADESH |
9005836579
sangeeta.sukham@18gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,GOVERNMENT AYURVEDIC COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J988||Other specified respiratory disorders. Ayurveda Condition: kasa, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Balchaturbhadra Churna, Reference: Bhaishajya Ratnavali -71/39, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 06(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Milk), Additional Information: -NA | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Balchaturbhadra Avaleha, Reference: NA, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 09(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Milk/Lukewarm Water), Additional Information: -NA |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either gender, caste, socio-economic status etc. With age group 3 to 16 year
Patients having classical clinical signs and symptoms of kasa
Patients having a complaint history within one month.
|
|
| ExclusionCriteria |
| Details |
Patients having age below 3 year
Patients having age above 16 year
Individuals suffering from systemic pathologies like SLE, Cancer, severe hormonal imbalance and tuberculosis AIDS etc
severe skin infection or allergies etc.
Patients on medication of Hormonal Therapy
|
|
|
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 |
| Improvement in kasa |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in other symptoms |
14 to 16 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
30/09/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Interventional study Patient suffering from kasa will selected from opd of government Ayurvedic College and Hospital chaukaghat Varanasi Total patient=60 Treatment plan Group A-30 patient will be treated with Balachaturbhdra churna Group B-30 patient will be treated with Balachaturbhdra avaleha |