| CTRI Number |
CTRI/2022/01/039180 [Registered on: 05/01/2022] Trial Registered Prospectively |
| Last Modified On: |
04/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical Trial of herbal formulation (GP/PROD/2021/004) in acute cough and throat irritation |
|
Scientific Title of Study
|
A randomized, controlled clinical study to compare efficacy of a polyherbal formulation (GP/PROD/2021/004) versus Standard Allopathic Formulation for relief of acute
nonproductive cough and throat irritation |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHC/CT/21-22/021 Version 1.0 dated 10 Nov 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amol Gothwad |
| Designation |
Consultant |
| Affiliation |
Lokmanya Medical Research Centre |
| Address |
4th floor, OPD 1, 314/B Telco Road, Chinchwad.
Pune
MAHARASHTRA
411033
India |
| Phone |
9766400243 |
| Fax |
|
| Email |
amol.gothwad87@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shridhar Pandya |
| Designation |
R&D coordinator |
| Affiliation |
Gplife Healthcare Pvt Ltd |
| Address |
705-706, Orbit- 1 Building Near RRTM Market , Punagam Saroli road, Surat- 395010
Surat
GUJARAT
395010
India |
| Phone |
|
| Fax |
|
| Email |
gplifehealthcare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Chetan savaliya |
| Designation |
Director |
| Affiliation |
Gplife Healthcare Pvt Ltd |
| Address |
705-706, Orbit- 1 Building Near RRTM Market , Punagam Saroli road, Surat- 395010
Surat
GUJARAT
395010
India |
| Phone |
|
| Fax |
|
| Email |
chetansavaliya21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gplife Healthcare Pvt Ltd 705-706, Orbit- 1 Building Near RRTM Market , Punagam Saroli road, Surat- 395010 |
|
|
Primary Sponsor
|
| Name |
Mr Kamlesh Thummar |
| Address |
Gplife Healthcare Pvt Ltd 705-706, Orbit- 1 Building Near RRTM Market , Punagam Saroli road, Surat- 395010 |
| Type of Sponsor |
Other [Director] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Mr Pritesh Shah |
Gplife Healthcare Pvt Ltd 705-706, ORBIT- 1 BUILDING NEAR RRTM MARKET , PUNAGAM SAROLI ROAD, SURAT- 395010 |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tanuja Panchabhai |
Atharv multispecialty Research center |
Krishna chowk, Kirti Nagar, New Sanghavi, Pune 411027
Pune
MAHARASHTRA |
9421885129
drtanuja.panchabhai@gmail.com |
| Dr Amol Gothwad |
Lokmanya Medical Research Centre |
4th floor, OPD 1, 314/B Telco Road,Chinchwad.
Pune
MAHARASHTRA |
9766400243
amol.gothwad87@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Lokmanya Medical Research Centre |
Approved |
| Institutional Ethics Committee Lokmanya Medical Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J069||Acute upper respiratory infection,unspecified. Ayurveda Condition: KASAH, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Benadryl cough formula syrup |
10 ml thrice a day for 5 days |
| Intervention |
polyherbal formulation (GP/PROD/2021/004) |
10 ml thrice a day with water for 5 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with H/O acute nonproductive cough and throat irritation for less than 1week duration
Males and Females between 18-65 years age
Patients who in the opinion of the Investigator will be able to comply with the study requirements
Patients with a cough score of 0, 1 or 2 during day time
Patients willing and able to provide signed informed consent for any study related procedures. |
|
| ExclusionCriteria |
| Details |
Patients with H/O lower respiratory tract infections such as Pneumonia, Tuberculosis, Bronchitis, Whooping cough.
Patients with H/O Chronic Obstructive Pulmonary
Diseases/Asthma
Patients with H/O underlying lung pathology such as lung abscess, cystic fibrosis.
Patients with known hypersensitivity to ingredients of Investigational Products
Patients with clinical suspicion of any systemic bacterial infection.
Patients with H/O Myocardial Infarction (MI) within 4 weeks prior to enrollment
Patients with immediate life threatening diseases such as pre-existing cardiovascular, liver or neoplastic disease. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. Changes in day and night frequencies of cough from baseline to end of treatment period on a 6-point scale
2. Change in throat irritation from baseline to end of treatment period on a 5-point scale |
Baseline Day, Day 1, Day 2, Day 3, Day 4, Day 5, and Day 15 |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1.Time to relief from cough and throat irritation on 5 point scale for first morning dose over a treatment period of 5 days
2.Duration of relief from symptoms on a 5 point scale for first morning dose over a treatment period of 5 days
3. Measure of drowsiness on a 2 point scale
4. Recurrence of cough after stoppage of medication. |
Baseline Day, Day 1, Day 2, Day 3, Day 4, Day 5, and Day 15 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="66" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
16/01/2022 |
| Date of Study Completion (India) |
28/12/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The clinical study is planned to evaluate clinical effectiveness of a polyherbal formulation (GP/PROD/2021/004) versus Standard
Allopathic Formulation for relief of acute nonproductive cough and throat
irritation.
|