A Randomized Double Dummy Double Blind Dose Determining Place-bo Controlled Study to Evaluate Efficacy of Investigational Product E-RH-06 at 2 Dose Levels for the Metabolic Management of Chronic or Recurrent, Non-infective Nasal Congestion With-or-without Rhinorrhea. (EB-RH-02-11)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Enovate Biolife Pvt Ltd.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Enovate Biolife Pvt Ltd
ClinicalTrials.gov Identifier:
NCT01546662
First received: March 2, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted
  Purpose

The study will be conducted in two phases. First phase will be 16 weeks study to assess the safety, efficacy & to determine the most appropriate dose. Will consist of following visits.

Phase II (Extended Follow-up): At the end of Day 112, an interim analysis will be conducted to assess the sustained efficacy of the investigational product and accordingly the study will enter into phase II.


Condition Intervention
Chronic Rhinitis
Dietary Supplement: E-RH-06
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: A Randomized Double Dummy Double Blind Dose Determining Place-bo Controlled Study to Evaluate Efficacy of Investigational Product E-RH-06 at 2 Dose Levels for the Metabolic Management of Chronic or Recurrent, Non-infective Nasal Congestion With-or-without Rhinorrhea.

Further study details as provided by Enovate Biolife Pvt Ltd:

Primary Outcome Measures:
  • TNSS Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To determine if the investigational product E-RH-06 relieves the symptoms of nasal congestion with-or-without rhinorrhea to a greater extent than placebo with 12 weeks' treatment as assessed by the pre-visit 24 hours reflective TNSS


Secondary Outcome Measures:
  • Reduction of frequency [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Reduction in TNSS at the end of 4 weeks as compared to baseline Reduction in Total Symptom Score (TSS) and/or Total Non Nasal Symptom Score (TNNSS) at the end of 4 weeks as compared to baseline Reduction in frequency of AR attacks at the end of 4 weeks as compared to baseline


Estimated Enrollment: 54
Study Start Date: October 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: E-RH-06 - Low Dose
1 Capsule twice daily
Dietary Supplement: E-RH-06
Capsules, 1 capsule/ 2 capsule, twice daily for 12 weeks
Other Name: Olfaclear
Experimental: E-RH-06 - High Dose
2 capsules twice daily
Dietary Supplement: E-RH-06
Capsules, 1 capsule/ 2 capsule, twice daily for 12 weeks
Other Name: Olfaclear
Placebo Comparator: Placebo ;
Placebo Comparator
Dietary Supplement: Placebo
1/ 2 capsules, twice daily for 12 weeks
Other Name: Placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:• Male and female subjects in the age group of 18-60 years with per-sistent or recurrent nasal congestion and/ or rhinorrhea as defined by the symptoms that last for not less than an hour.

  • Demonstrating baseline average 24 hour TNSS ≥10.
  • No clinical evidence of infection indicated by mucopurulent or puru-lent discharge, fever, and tenderness over paranasal sinuses.
  • Subjects who will be able to read and fill-up subject diary efficiently.
  • Able and willing to give informed consent.
  • Able and willing to follow all study related instructions and to make all required visits.

Exclusion Criteria:• Subjects who have taken systemic, topical corticosteroids, long acting antihistamines or immunosuppressive medication within last 4 weeks or planning to take them within the course of the study.

  • Acute febrile illness (such as cold, flu etc.) within one week of enroll-ment.
  • Subjects with nasal structure deformities, nasal polyps, severe deviat-ed nasal septum and hypertrophic rhinitis will be excluded from the study.
  • Clinical history of allergy/ hypersensitivity to one or more products of herbal origin.
  • Pregnant / lactating women and women who are planning to get preg-nant
  • Recent (within last 3 months) participation in a clinical trial
  • Recent (within last 15 days) use of any herbal product for the indication under study
  • Patients with severe conditions of chronic sinusitis deviated nasal sep-tum or nasal polyposis.
  • Bronchial asthma patients on loading/ maintenance therapy of theophy-line.
  • Patients requiring continuous use of laxatives.
  • Major chronic disease of liver, kidney, CVS or CNS and other body systems
  • A psychiatric condition or chronic alcohol or drug abuse problem, determined from the patient's medical history, which in the Investigator's opinion may pose a threat to patient compliance.
  • Subjects otherwise judged by the investigator or sub -investigator to be inappropriate for inclusion in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01546662

Locations
India
Shree sidhi clinic Recruiting
Mumbai, Maharashtra, India, 400068
Contact: Dr. Sanjay Palimkar, M.B.B.S    9821118227    drsmpalimkar@yahoo.in   
Contact: Ms. Anushka Avhere    9869701571    asavhere@yahoo.co.in   
Principal Investigator: Dr. Sanjay Palimkar, M.B.B.S         
The Clinic Recruiting
Mumbai, Maharashtra, India, 400068
Contact: Dr. Rajesh Kewalramani, M.B.B.S    9820024766    rajeshtarna@hotmail.com   
Contact: None         
Principal Investigator: Dr. Rajesh Kewalramani, M.B.B.S         
Chirayu Clinic Recruiting
Nasik, Maharashtra, India, 422002
Contact: Dr. Anirban Bandopadhyay, M.B.B.S,D.N.B Chest    9890712199    anbandu@yahoo.com   
Contact: Dr. Deepak Ghumare, B.H.M.S,PGDCR    8149584321    deepakgumare@gmail.com   
Principal Investigator: Dr. Anirban Bandopadhayay, MBBS,D.N.B         
Suyog Hospital Recruiting
Nasik, Maharashtra, India, 422003
Contact: Dr. Kailash Rathi, M.B.B.S,D.N.B    9422254748      
Contact: Dr. Deepak Ghumare, B.H.M.S, PGDCR    8149584321    deepakghumare@gmail.com   
Principal Investigator: Dr. Kailash rathi, MBBS,D.N.B         
Sponsors and Collaborators
Enovate Biolife Pvt Ltd
Investigators
Study Chair: Dr. Shalini Shrivastava, M.D Enovate Biolife Pvt Ltd
  More Information

No publications provided

Responsible Party: Enovate Biolife Pvt Ltd
ClinicalTrials.gov Identifier: NCT01546662     History of Changes
Other Study ID Numbers: EB-RH-02-11, EB-ERH-02-11
Study First Received: March 2, 2012
Last Updated: March 2, 2012
Health Authority: India: Institutional Review Board

Keywords provided by Enovate Biolife Pvt Ltd:
Rhinitis

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on October 30, 2014