| CTRI Number |
CTRI/2024/08/072488 [Registered on: 13/08/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To check if Pippalyadi Churna is having any effect in Kaphaja Kasa (cough) |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study to evaluate the efficacy of Pippalyadi Churna in Kaphaja Kasa |
| 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 Betsi Mary Kharbyngar |
| Designation |
PG Scholar |
| Affiliation |
Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodubidire, Dakshina Kannada |
| Address |
Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodubidire, Dakshina Kannada, Karnataka-574227, Department of Kaumarabhritya, OPD room no. 2, ground floor
Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodubidire, Dakshina Kannada, Karnataka-574227, Department of Kaumarabhritya, OPD room no.2, ground floor
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9774820965 |
| Fax |
|
| Email |
betsymarykharbyngar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jithesh Chowta |
| Designation |
Associate Professor |
| Affiliation |
Alvas Ayurveda Medical College and Hospital, Moodubidire |
| Address |
Department of Kaumarabhritya, Alvas Ayurveda Medical College and Hospital, Moodubidire -574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9164123167 |
| Fax |
|
| Email |
jitheshchowta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jithesh Chowta |
| Designation |
Associate Professor |
| Affiliation |
Alvas Ayurveda Medical College and Hospital, Moodubidire |
| Address |
Department of Kaumarabhritya, Alvas Ayurveda Medical College and Hospital, Moodubidire -574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9164123167 |
| Fax |
|
| Email |
jitheshchowta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas Ayurveda Medical College and Hospital, Moodubidire, Dakshina Kannada, Karnataka, India-574227 |
|
|
Primary Sponsor
|
| Name |
Dr Betsi Mary Kharbyngar |
| Address |
Alvas Ayurveda Medical College and Hospital, Moodubidire, Dakshina Kannada, Karnataka-574227 |
| 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 Betsi Mary Kharbyngar |
Alvas Ayurveda Medical College and Hospital |
Department of Kaumarabhritya, Alvas Ayurveda Medical College and Hospital Moodubidire, Dakshina Kannada, Karnataka-574227, OPD room no.2, ground floor.
Dakshina Kannada
KARNATAKA |
9774820965
betsymarykharbyngar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Alvas Ayurveda Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J399||Disease of upper respiratory tract, unspecified. Ayurveda Condition: KASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Pippalyadi Churna , Reference: Astanga Samgraha , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3.5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: For 6 to 8 years of age, a dose of 3.5 gms will be given twice a day and from 9 to 12 years of age, a dose of 5.5 gms will be
given twice a day. |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA:
1. Subjects irrespective of gender, religion and socio economic status aged between 06 to 12 years.
2. Subjects with any two or more symptoms described in the context of Kaphaja Kasa will be selected.
3. Kaphaja Kasa of less than 7 days duration will be selected.
|
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA:
1. Kaphaja Kasa as Anubandha Lakshana or Upadrava of other diseases.
2. Subjects having any other systemic diseases.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To check and assess the following parameters
Cough
Number of bouts of cough in one hour.
Throat congestion
Nasal discharge
Quality and consistency of sputum.
Additional breath sounds on auscultation
|
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To reduce the repeated occurrence of cough. |
14 days |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/11/2024 |
| 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="6"
Days="15" |
|
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
|
The study is randomized, parallel group, actively controlled comparative clinical study with Bharangyadi churna as standard drug and Pippalyadi Churna as interventional drug with the dosage of 3.5gms for 6 to 8 years and 5.5gms for 9 to 12 years to be given twice a day after food with madhu as anupana. The study will be conducted on subjects having Kaphaja Kasa belonging to the age group of 6 to 12 years who has given written and verbal consent by parents for undergoing clinical study. The study will be conducted in Alvas Ayurveda Medical College and Hospital, Moodubidire. Interventional period of the study is 14days and assessment will be done before treatment, 3rd day, 7th day and 14th day. |