| CTRI Number |
CTRI/2024/03/064200 [Registered on: 15/03/2024] Trial Registered Prospectively |
| Last Modified On: |
15/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study to assess the effectiveness of Hariras Ayurvedic pills for symptomatic relief of Cough and Throat Irritation
|
|
Scientific Title of Study
|
An Open-label, single-arm clinical trial to evaluate Efficacy and Safety of Hariras Ayurvedic pills for symptomatic relief of acute nonproductive Cough and Throat Irritation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHC/CT/23-24/048 Version: 1.00 dated 14 Feb 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amol Gothwad |
| Designation |
Principal Investigator |
| Affiliation |
Lokmanya Medical Research Centre and Hospital |
| Address |
Fourth floor OPD 401,314 B Telco Road Chinchwad
Pune
MAHARASHTRA
411039
India |
| Phone |
9766400243 |
| Fax |
- |
| Email |
amol.gothwad87@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Manish Jayatilal Bhardwaj |
| Designation |
Managing Director |
| Affiliation |
Sushrutkrupa Ayurvedic Pharmacy Pvt. Ltd. |
| Address |
Plot No. Four, Maruti Industrial Estate, Rajnagar Patiya, Santej Khtraj Road, Santej
Ahmadabad
GUJARAT
380060
India |
| Phone |
9824254187 |
| Fax |
- |
| Email |
sushrutkrupa.ayurved@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Manish Jayatilal Bhardwaj |
| Designation |
Managing Director |
| Affiliation |
Sushrutkrupa Ayurvedic Pharmacy Pvt. Ltd. |
| Address |
Plot No. Four, Maruti Industrial Estate, Rajnagar Patiya, Santej Khtraj Road, Santej
Ahmadabad
GUJARAT
380060
India |
| Phone |
9824254187 |
| Fax |
- |
| Email |
sushrutkrupa.ayurved@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sushrutkrupa Ayurvedic Pharmacy Pvt. Ltd.
4, Maruti Industrial Estate, Rajnagar Patiya, Santej Khtraj Road, Santej-380060- Gujarat(India) |
|
|
Primary Sponsor
|
| Name |
Sushrutkrupa Ayurvedic Pharmacy Pvt. Ltd. |
| Address |
4, Maruti Industrial Estate, Rajnagar Patiya, Santej Khtraj Road, Santej-380060- Gujarat(India) |
| 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 Amol Gothwad |
Lokmanya Medical Research Centre |
Fourth floor OPD 401,
314 B Telco Road
Chinchwad
Pune
MAHARASHTRA |
9766400243
-
amol.gothwad87@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Lokmanya Medical Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J09-J18||Influenza and pneumonia. Ayurveda Condition: KASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Hariras Pills, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: sos, Bhaishajya Kal: Muhurmuhu, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: - |
|
| Intervention |
Hariras Ayurvedic pills |
One Hariras Ayurvedic pills 08 to 10 times per day for five days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female subjects (18 to 65 years of age) with history of acute nonproductive cough and throat irritation for less than 1week duration
2. Subjects with a cough score of 0, 1, or 2 during daytime
3. Subjects willing and able to provide signed informed consent forms before any study-related procedures.
4. Subjects willing to abstain from other medication (allopathic or herbal) for cough treatment during the study period
5. Subjects who in the opinion of the Investigator will be able to comply with the study requirements
|
|
| ExclusionCriteria |
| Details |
1. Subjects with a history of lower respiratory tract infections such as Pneumonia, Tuberculosis, Bronchitis, and Whooping cough.
2. Subjects with a history of Chronic Obstructive Pulmonary Diseases, Asthma
3. Subjects with a history of underlying lung pathology such as lung abscess, or cystic fibrosis.
4. Subjects with known hypersensitivity to any ingredients of the investigational products
5. Subjects with clinical suspicion of any systemic bacterial infection.
6. Subjects with a history of Myocardial Infarction (MI) within 4 weeks before enrollment
7. Subjects with immediate life-threatening diseases such as pre-existing cardiovascular, liver or neoplastic disease.
8. Subjects who had received any sedative, hypnotic or tranquilizer within 14 days before randomization
9. Subjects who had received any of the anti-histamines, cough suppressants, mucolytics, expectorants, or antibiotics within 3 days before randomization.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change 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
|
At Screening, Baseline, Day 1, Day 2, Day 5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Time to relief from cough & throat irritation on a 5-point scale for first morning dose over a treatment period of 05 days
2. Duration of relief from symptoms (related to acute nonproductive cough) 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
|
At Screening, Baseline, Day 1, Day 2, Day 5 |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/03/2024 |
| Date of Study Completion (India) |
25/03/2024 |
| Date of First Enrollment (Global) |
25/03/2024 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
After receiving Ethics committee’s approval for
study protocol, clinical study will be registered on CTRI website. Male and female subjects between 18 to 65 years
of age with history of acute nonproductive cough and throat irritation for less
than 1week duration will be screened for eligibility criteria. On screening visit, a written informed consent
will be obtained from subject confirming participation in the study. Subject’s
medical and medication history and demographic details will be taken. Subject’s
current medication if any will be noted in the case record from (CRF). Physical
examination and vitals will be recorded. The subject will be considered for
further evaluation as per the inclusion and exclusion criteria. On the Baseline visit, subjects will be
recruited in the study if they meet all the inclusion criteria and will then be
randomized to the respective study groups as per the computer-generated
randomization list. At the Baseline visit, cough frequency during
day and night will be recorded. Throat irritation and other symptoms will be
assessed on a 5-point scale. The subject will be provided with
investigational products and advised to consume One Hariras pill 08 to 10 times
per day of investigational product. Subjects will be called at respective study
sites for follow-up visits on Days 2 and 5. At each follow-up visit, cough frequency during
day and night will be recorded. Throat irritation and other symptoms will be
assessed on a 5-point scale. Drowsiness will be assessed on 2-point scale.
Clinical signs and symptoms related to acute nonproductive cough will be
assessed on a 5-point scale. After completion of 5 days of study treatment,
response to treatment will be assessed based on changes in the frequency of
cough and throat irritation from the Baseline to the end of Day 5 in both the
treatment groups. The subject will be asked to stop the
investigational product and take the advice of the investigator for further
treatment. Post-study safety
evaluations will be done. The subject
will be closely monitored for any adverse event starting from the baseline
visit till the end of the study visit. |