NCT01546662

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

March 7, 2012

Status Verified

March 1, 2012

Enrollment Period

7 months

First QC Date

March 2, 2012

Last Update Submit

March 2, 2012

Conditions

Chronic Rhinitis

Keywords

Rhinitis

Outcome Measures

Primary Outcomes (1)

  • TNSS Score

    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

    12 weeks

Secondary Outcomes (1)

  • Reduction of frequency

    4 weeks

Study Arms (3)

E-RH-06 - Low Dose

EXPERIMENTAL

1 Capsule twice daily

Dietary Supplement: E-RH-06

E-RH-06 - High Dose

EXPERIMENTAL

2 capsules twice daily

Dietary Supplement: E-RH-06

Placebo ;

PLACEBO COMPARATOR

Placebo Comparator

Dietary Supplement: Placebo

Interventions

E-RH-06DIETARY_SUPPLEMENT

Capsules, 1 capsule/ 2 capsule, twice daily for 12 weeks

Also known as: Olfaclear
E-RH-06 - High DoseE-RH-06 - Low Dose
PlaceboDIETARY_SUPPLEMENT

1/ 2 capsules, twice daily for 12 weeks

Placebo ;

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Shree sidhi clinic

Mumbai, Maharashtra, 400068, India

RECRUITING

The Clinic

Mumbai, Maharashtra, 400068, India

RECRUITING

Chirayu Clinic

Nashik, Maharashtra, 422002, India

RECRUITING

Suyog Hospital

Nashik, Maharashtra, 422003, India

RECRUITING

MeSH Terms

Conditions

Rhinitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Dr. Shalini Shrivastava, M.D

    Enovate Biolife Pvt Ltd

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2012

First Posted

March 7, 2012

Study Start

October 1, 2011

Primary Completion

May 1, 2012

Study Completion

June 1, 2012

Last Updated

March 7, 2012

Record last verified: 2012-03

Locations

IN(4)