| CTRI Number |
CTRI/2021/02/031045 [Registered on: 05/02/2021] Trial Registered Prospectively |
| Last Modified On: |
12/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
study to find the effectiveness and safety of Sinuset tablets in patients suffering from Sinusitis and/or Allergic Rhinitis |
|
Scientific Title of Study
|
A prospective, multicenter, double blind, placebo controlled randomized clinical trial to evaluate efficacy and safety of Sinuset tablets in patients suffering from Sinusitis and/or Allergic Rhinitis |
| Trial Acronym |
CT-IR-AR- 2020 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Devesh Kumar |
| Designation |
Director Clinical Trial Operations |
| Affiliation |
IR Innovate Research Private Limited |
| Address |
IR Innovate Research Private Limited, Room No.- B-1 D -13 Sector - 03
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
01204310639 |
| Fax |
|
| Email |
devesh.kumar@innovate-research.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devesh Kumar |
| Designation |
Director Clinical Trial Operations |
| Affiliation |
IR Innovate Research Private Limited |
| Address |
IR Innovate Research Private Limited, Room No.- B-1 D -13 Sector - 03
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
01204310639 |
| Fax |
|
| Email |
devesh.kumar@innovate-research.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Devesh Kumar |
| Designation |
Director Clinical Trial Operations |
| Affiliation |
IR Innovate Research Private Limited |
| Address |
IR Innovate Research Private Limited, Room No.- B-1 D -13 Sector - 03
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
01204310639 |
| Fax |
|
| Email |
devesh.kumar@innovate-research.com |
|
|
Source of Monetary or Material Support
|
| BHARGAVA PHYTOLAB B 92, Sector2,
Noida, U.P India
PIN 201301 |
|
|
Primary Sponsor
|
| Name |
BHARGAVA PHYTOLAB |
| Address |
B 92, Sector2,
Noida, U.P India
PIN 201301 |
| 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 |
| DrMoni Jha |
Panchsheel Hospital Private Limited |
Room no 1 Research Department C-3/63A 64A Yamuna Vihar Opp Gokalpuri Delhi 110053
New Delhi
DELHI |
9599493837
moni.jha0820@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Panchsheel Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J019||Acute sinusitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
2 tablets to be taken thrice daily orally for 14 days |
| Intervention |
Sinuset tablets |
Each tablet contains:
Asafoetida 12X 20.00
Lycopodium clavatum 3X 25.00
Pulsatilla nigricans 6X 20.00
2 tablets to be taken thrice daily orally for 14 days
Sticta pulmonaria 3X 10.00
Lemna minor 3 X 60.00
Echinacea purpurea 3X 20.00
Sambucus Nigra 4X 18.00
Armoracia Sativa 4X 10.00
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subject is willing and able to give written informed consent.
Patients of either sex aged between 18 to 65 years
Subject having clinical diagnosis as per investigator’s judgment for Acute or Chronic Sinusitis and/or Allergic Rhinitis.
Subjects of childbearing potential should have a negative Pregnancy test at Screening.
Female subjects of childbearing potential should be willing to practice appropriate birth control during the entire duration of the study.
Appropriate birth control is defined in the study as any medically recommended method (or combination of methods) except oral birth control pills as per standard of care.
Subject is willing, able and likely to comply with all study procedures and restrictions.
|
|
| ExclusionCriteria |
| Details |
Patients who are suspicious or diagnosed for pneumonia
Patients with chronic bronchitis, Chronic Obstructive Pulmonary Disease (COPD), bronchiolitis, asthma, bronchial asthma or other LRTI
Patients with Deviated Nasal Septum
Patients with active infection who needs administration of antibiotics
Patients with myocardial infarction, congestive heart failure
Patients with renal disorder or liver disorder
Patients with hypotension or hypertension
Patients with history of epilepsy
Patients with hyperthyroidism
Patients with gastroduodenal ulcer
Patients with severe hypoxemia
Patients who are in drug or therapy or planned to have- Antibiotics, anti-virus, and systemic or inhalation glucocorticosteroids: from 2 weeks prior to administration of investigational product to termination of clinical trial
Secretolytics/mucolytics, expectorants, antitussives, herbal medicines which has antitussive or expectorant effect: from 2 days prior to administration of investigational product to termination of clinical trial
Analgesics except acetaminophen, antihistamines, β2-agonists, bronchodilators which includes anticholinergic agents, xanthine derivatives, central nervous system stimulants, drug which is known for interaction between acebrophylline (cimetidine, alloprinol, oral anticoagulants, furosemide, reserpine, barbiturates, phenytoin) and symptomatic therapy for other therapy for acute bronchitis: whole period for clinical trial
Smokers
Patients who have history for drug hypersensitivity or allergic reaction in component of investigational product or similar drug
Patients who are pregnant and/or breast feeding.
Patients with no intention to use appropriate contraceptives or has a plan to become pregnant
Patients who had an administration of other investigational product or medical device for clinical trial 4 weeks prior to participation of clinical trial
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the change or improvement in SNOT -20 (Sino Nasal Outcome Test) |
Day 0 to Day 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Safety and tolerability of the study drug(s) will be assessed by the
Clinical AEs occurring during entire duration of study |
Day 0 to Day 14 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
12/02/2021 |
| Date of Study Completion (India) |
30/09/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Data would be published if required. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Sinusitis is a common inflammation of the
paranasal sinuses, the cavities that produce the mucus necessary for the nasal
passages to work effectively.
It can be acute or
chronic, and it can be caused by viruses, bacteria, fungi, allergies, or even
an autoimmune reaction.
Sinusitis is an inflammation of your sinuses. Your sinuses are the
hollow passages in the bones surrounding your nose. They produce mucus to keep
your nasal passages moist, and they drain into your nasal cavity.
Infections are a common cause of sinusitis. Infections can develop if
the passages that drain into your nose get blocked or plugged. If you have
sinusitis you may feel pressure in your sinuses and have mucus drainage in the
back of the throat, called postnasal drip
Allergic rhinitis is a diagnosis
associated with a group of symptoms affecting the nose. These symptoms occur
when you breathe in something you are allergic to, such as dust, animal dander,
or pollen. Symptoms can also occur when you eat a food that you are allergic
to.
Study Rational : The clinical study is being conducted to evaluate
extended efficacy and safety of Sinuset Tablets.
Study Design: A
prospective, multicenter, double blind, placebo controlled randomized clinical
trial to evaluate efficacy and safety of Sinuset tablets in patients suffering from Sinusitis
and/or Allergic Rhinitis
Subjects suffering from Acute or Chronic Sinusitis and/or Allergic
Rhinitis
Investigational products-
1.
Sinuset tablets to be taken 2
tablets three times a day
2.
Placebo
Dosage - 2
tablets to be taken thrice daily, for 14 days
|