CTRI Number |
CTRI/2020/06/025559 [Registered on: 02/06/2020] Trial Registered Prospectively |
Last Modified On: |
03/08/2020 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Siddha |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Evaluation of Siddha herbal formulation, Vipro, in the management of uncomplicated respiratory infections |
Scientific Title of Study
|
A single centre, prospective, randomized, open labelled clinical study to evaluate the effectiveness of Siddha herbal formulation, Vipro, in uncomplicated respiratory infections |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr R Arunkumar |
Designation |
Professor of Pharmacology and Vice Principal |
Affiliation |
Chettinad Hospital and Research Institute, Chettinad Academy of Research and Education |
Address |
Chettinad Healthcity campus, Kelambakkam, Chengalpattu DT, Old Kancheepuram DT
Kancheepuram TAMIL NADU 603103 India |
Phone |
9884212644 |
Fax |
|
Email |
arunkumarr@chettinadhealthcity.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr R Arunkumar |
Designation |
Professor of Pharmacology and Vice Principal |
Affiliation |
Chettinad Hospital and Research Institute, Chettinad Academy of Research and Education |
Address |
Chettinad Healthcity campus, Kelambakkam, Chengalpattu DT, Old Kancheepuram DT
TAMIL NADU 603103 India |
Phone |
9884212644 |
Fax |
|
Email |
arunkumarr@chettinadhealthcity.com |
|
Details of Contact Person Public Query
|
Name |
Dr R Arunkumar |
Designation |
Professor of Pharmacology and Vice Principal |
Affiliation |
Chettinad Hospital and Research Institute, Chettinad Academy of Research and Education |
Address |
Chettinad Healthcity campus, Kelambakkam, Chengalpattu DT, Old Kancheepuram DT
TAMIL NADU 603103 India |
Phone |
9884212644 |
Fax |
|
Email |
arunkumarr@chettinadhealthcity.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Buy Happy Marketing LLP |
Address |
Prince Info Park, Tower B, 2nd Floor
2nd Main Road, Ambattur Industrial Estate, Chennai 600058 |
Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
|
Name |
Address |
Qscience Therapeutics |
9 A, Maaruthi Emerald, Rajalakshmi Avenue, 4th Cross, Perungudi, Chennai – 600 096 |
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Tamilnadu India |
Chettinad Hospital and Research Institute |
Chettinad Health City campus, Rajiv Gandhi Salai, Kelambakkam Kancheepuram TAMIL NADU |
04447413322
arunkumarr@chettinadhealthcity.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Human Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: J00||Acute nasopharyngitis [common cold], (2) ICD-10 Condition: J029||Acute pharyngitis, unspecified, (3) ICD-10 Condition: J069||Acute upper respiratory infection,unspecified, (4) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Siddha herbal formulation, Vipro |
The traditional medicinal ingredients of the product processed with essential oil from Cocus nucifera L, as base have been scientifically proven to ward off respiratory infectious diseases. It includes, Ocimum basilicum L, Curcuma longa L, Citrus lemon L, Allium sativum L, Plectranthus amboinicus Lour, Momordica charantia L, Cinnamomum verum J.Presl, Zingiber officinale Rosc and Piper nigrum L. The crude extracts of these plant parts have been proven to have anti-bacterial, anti-viral and immunomodulatory as well as anti-inflammatory properties. |
Comparator Agent |
Standard treatment |
symptomatic management with antipyretics and / or antihistamines and / or nasal decongestants and / or antibiotics and / or cough syrups for duration of 3 to 5 days as decided by the treating physician |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1. Having uncomplicated respiratory infections, at least for less than 5 days, diagnosed with clinical symptoms and signs of fever, myalgia, rhinitis, sore throat, throat pain, cough, expectoration and head ache
2. Consenting to participate in the study and sign the informed consent
|
|
ExclusionCriteria |
Details |
1. Patients with uncontrolled co-morbid conditions like Diabetes mellitus, Hypertension and Bronchial asthma
2. Patients with Lower respiratory tract infections, Chronic Bronchitis, Chronic obstructive air way problems
3. Patients with significant Cardiovascular, Neurological , Psychiatric, Gastro intestinal and other system infections or disorders and malignancies
4. Hypersensitivity to the herbal ingredients in the formulations and other medications prescribed in the study
5. Pregnant and feeding mothers
6. When the patients are interviewed for selection, all those patients who come under the testing criteria for COVID-19 as per ICMR guidelines will be tested for COVID – 19 and if they are found to be positive, they will be excluded from participating in the study. |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
1. Reducing the severity of clinical symptoms such as fever, myalgia, rhinitis, sore throat, throat pain, cough, expectoration and head ache |
Daily for 7 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. Reducing the worsening of clinical symptoms
2. Reducing the complications |
Daily for 7 days |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
15/06/2020 |
Date of Study Completion (India) |
31/07/2020 |
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)?
|
Brief Summary
|
This study is a single centre, prospective, randomized, open labeled clinical study to evaluate the effectiveness of Siddha herbal formulation, Vipro, towards the management of uncomplicated respiratory infection including common cold with / without fever, flu like respiratory infection, bacterial respiratory infection and unidentified SARS-CoV-2-like respiratory infection. The patients will be enrolled at Chettinad Hospital and Research Institute, Kelambakkam, with prior informed consent. The subjects will be grouped into three as follows. Group 1: Standard treatment (symptomatic management with antipyretics and / or antihistamines and / or nasal decongestants and / or antibiotics and / or cough syrups for duration of 3 to 5 days as decided by the treating physician) Group 2: Liquid, oral, poly herbal formulation ‘Vipro’, one teaspoon of formulation, mixed in a glass of water, mixed thoroughly and swallowed after food for 7 days, for four times a day, morning, afternoon, evening and night. Group 3: Standard Treatment + Vipro combination will be advised as in group 1 and 2 Baseline assessment on day 0: The patients who fulfill the inclusion and exclusion criteria will be enrolled in the study. They will be allocated to any of the treatment groups as per the randomization. The following baseline data will be collected. - Demographic profile - age, gender, height, weight and BMI will be recorded
- Blood pressure, Pulse, SpO2, Respiratory rate, Body temperature and constitutional symptoms
- General examination, systemic clinical examination
- Complete blood count (with 5 ml of blood drawn) and Throat / Nasal swab for bacterial culture and sensitivity
- Chest X ray and Nasal / Throat swab for COVID - when indicated as per the opinion of the treating physician
After the baseline assessment, the subjects will be provided with any one of the following treatments. Group 1: Symptomatic management with antipyretics and / or antihistamines and / or nasal decongestants and / or antibiotics and / or cough syrups for duration of 3 to 5 days as decided by the treating physician Group 2: Liquid, oral, poly herbal formulation ‘Vipro’, one teaspoon of formulation, mixed in a glass of water, mixed thoroughly and swallowed after food for 7 days, for four times a day, morning, afternoon, evening and night. Group 3: Combination of both treatments of group 1 and 2 Follow up assessment (days 1 to 7): Telephonic follow up (days 1 to 7) – Reminder for medication intake (daily once), Adverse events (daily once), Clinical symptoms for improvement / worsening (daily once), body temperature and constitutional symptoms Physical follow up (On days 4 and 7) – Checking medication compliance, Blood pressure, Pulse, SpO2, Respiratory rate, Body temperature, constitutional symptoms, adverse events, General and Systemic examination, clinical signs and symptoms During follow up - Complete blood count (with 5 ml of blood drawn) and Throat / Nasal swab for culture and sensitivity on day 7. Chest X ray and Throat / Nasal swab for COVID - when indicated as per the opinion of the treating physician. If the subjects are found to deteriorate with the treatments followed, they will be withdrawn from the study and suitable alternate treatment will be provided. |