| CTRI Number |
CTRI/2019/12/022588 [Registered on: 31/12/2019] Trial Registered Prospectively |
| Last Modified On: |
20/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
“Study of Kuka cough lozenges in Kasa (acute coughing and throat irritation)†|
|
Scientific Title of Study
|
“A open clinical trial to evaluate the efficacy of Kuka cough lozenges variants in the patient suffering with Kasa (Acute cough and throat irritation).†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NOT REGISTERED ELSEWHERE |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gopesh Mangal |
| Designation |
Associate professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Panchkarma, National Institute of Ayurveda
Jaipur
RAJASTHAN
302002
India |
| Phone |
8619849011 |
| Fax |
|
| Email |
gmangal108@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Himanshu S Tiwari |
| Designation |
Medical advisor |
| Affiliation |
Multani Pharmaceutical Ltd |
| Address |
Medical Advisor Room, Pharmacy Division, Multani Pharmaceutical Ltd, T-10, Okhla industrial area, Phase-II.
New Delhi
DELHI
110020
India |
| Phone |
9654350714 |
| Fax |
|
| Email |
dr.hstiwari@multani.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi Mutha |
| Designation |
Lecturer ( Co investigator) |
| Affiliation |
National Institute of Ayurved |
| Address |
P.G Dept. of Kayachikitsa, National Institute of Ayurveda,
Jaipur
RAJASTHAN
302002
India |
| Phone |
9413102151 |
| Fax |
|
| Email |
rashmimutha21@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Multani Pharmaceuticals Ltd |
|
|
Primary Sponsor
|
| Name |
Multani Pharmaceuticals Ltd |
| Address |
T-10, Okhla industrial area, Phase-II, Okhla, New Delhi, 110020. |
| 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 Gopesh Mangal |
National Institute of Ayurveda |
OPD room no 2 and IPD, Department of Panchkarma, National Institute of Ayurveda
Jaipur
RAJASTHAN |
8619849011
gmangal108@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J069||Acute upper respiratory infection,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kuka Cough Lozenges |
Group A: Kuka Cough Lozenges (Tulsi mint)
Group B: Kuka Cough lozenges (Tulsi ginger)
Group C: Kuka Cough Lozenges (Tulsi Lemon)
Group D: Kuka Cough Lozenges (Tulsi orange)
Dose: 1 lozenge Q.I.D for 3 days
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Males and females with a history of acute cough due to any cause except those listed in exclusion criteria.
2. Throat irritation for <1 week duration, who will be able to comply with the study requirements
3. Patients having a cough score of 0, 1 or 2 during day time (as per Day Time Cough Scale described under end points)
4. Patients willing and able to provide signed ICF prior to study |
|
| ExclusionCriteria |
| Details |
1. Participants with a history of acute lower respiratory tract infections such as pneumonia, bronchitis whooping cough, chronic obstructive pulmonary disease/asthma, tuberculosis, systemic bacterial infections for which specific drug therapy will be required;
2. Any underlying lung pathology such as lung abscess or cystic fibrosis
3. Individuals with a history of myocardial infarction within 4 weeks prior to enrollment;
4. Individuals with a history of Parkinson’s disease and who were on monoamine oxidase inhibitors.
5. Individuals with any psychiatric illness which may impair the ability to provide written ICF.
6. Individuals participating in any other clinical trial.
7. Pregnant or lactating females.
8. Those who are under study treatment or any other condition due to which individuals are deemed unsuitable by the investigator for reason(s) not specifically stated in the exclusion criteria
9. Alcohol, smoke, and drug abusers will be excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in day/night time cough scales and throat irritation will be evaluated over a period of 3 days from baseline on verbal category descriptive (VCD) scale scores |
8 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time to relief from cough and throat irritation for all the first morning doses, duration of relief from symptoms for all first morning doses, drowsiness, and Physician’s Global Assessment of efficacy evaluated at visit 4 in both the treatment groups on VCD scales |
8 Days |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/01/2020 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
TO EVALUATE THE EFFICACY OF KUKA COUGH LOZENGES VARIANTS IN THE PATIENT SUFFERING WITH KASA (ACUTE COUGH AND THROAT IRRITATION)†volume 10, issue 10 october 21, PRINT ISSN NO. 2250-1991 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The present research project is for a randomized clinical trial to evaluate the safety and efficacy of Kuka cough lozenges variants in the subjects suffering with acute cough and throat irritation proposed to be carried out at NIA, Jaipur. Kuka cough lozenges (KCL) has four variants which are KCL Tulsi orange, KCL Tulsi ginger, KCL Tulsi lemon and KCL Tulsi mint. 120 Subjects will be randomly recruited from the OPD NIA, Jaipur, who will fulfill the inclusion criteria and will willing and able to provide signed informed consent form (ICF) prior to the study initiation and will be divided into 4 Groups. For each variant one group will be created and, 30 patients will be recruited in each group. Effect of the lozenges will assessed after 2 hours of administration on Day 1 and then on Day 3. Day 0 will be considered as baseline and effect of the therapy will be analyzed on the basis of it. Follow up of the subjects will be for 5 days for checking the recurrence of disease. Plan of analysis (analysis of data): For statistical analysis of data ANOVA, wilcoxan test will be used to analyzed and compare the subjective measures. P value <0.05 will be considered as significant. |