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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.

NCT01546662 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2012-03-07

No results posted yet for this study

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.

Conditions

  • Chronic Rhinitis

Interventions

DIETARY_SUPPLEMENT

E-RH-06

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

DIETARY_SUPPLEMENT

Placebo

1/ 2 capsules, twice daily for 12 weeks

Sponsors & Collaborators

  • Enovate Biolife Pvt Ltd

    lead INDUSTRY

Principal Investigators

  • Dr. Shalini Shrivastava, M.D · Enovate Biolife Pvt Ltd

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-05-31
Completion
2012-06-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01546662 on ClinicalTrials.gov