Chronic RhinitisEB-RH-02-11NCT01546662
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.
A study testing E-RH-06 in people with Chronic Rhinitis, run by Enovate Biolife Pvt Ltd at 4 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Rhinitis
- What is being tested?
- E-RH-06
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 4 sitesIndia
- Study dates
- Oct 2011to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Trial locations and contacts
4 sites in 1 country.
India4 sites, 4 recruiting
- Recruiting
Shree sidhi clinic
Mumbai, Maharashtra, 400068
Dr. Sanjay Palimkar, M.B.B.S, 9821118227, drsmpalimkar@yahoo.in
Ms. Anushka Avhere, 9869701571, asavhere@yahoo.co.in
- Recruiting
The Clinic
Mumbai, Maharashtra, 400068
Dr. Rajesh Kewalramani, M.B.B.S, 9820024766, rajeshtarna@hotmail.com
Dr. Rajesh Kewalramani, M.B.B.S
- Recruiting
Chirayu Clinic
Nashik, Maharashtra, 422002
Dr. Anirban Bandopadhyay, M.B.B.S,D.N.B Chest, 9890712199, anbandu@yahoo.com
Dr. Deepak Ghumare, B.H.M.S,PGDCR, 8149584321, deepakgumare@gmail.com
- Recruiting
Suyog Hospital
Nashik, Maharashtra, 422003
Dr. Kailash Rathi, M.B.B.S,D.N.B, 9422254748
Dr. Deepak Ghumare, B.H.M.S, PGDCR, 8149584321, deepakghumare@gmail.com
About this study
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.
Read the detailed description
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:
Screening I (Day -14) Visit: After obtaining written informed consent, subjects will be screened for study eligibility as per the inclusion/exclusion criteria defined in the study protocol on screening visit. The screening evaluations will include general examination, medical history taking, recording of vital parameters and assessment of frequency of symptoms, and Total Nasal Symptom Score (TNSS) calculation. Blood sample will be collected for CBC, SGPT \& Urine creatinine analysis. Simultaneously urine samples will be collected for urine routine \& UPT analysis. ECG will be performed.
Screening II (Day -7) Visit: Laboratory results and ECG reports will be analysed by the investigator. Eligible subjects will be entered into 7 days run-in period. Rescue medication will be dispensed.
Baseline Visit/ Randomization Visit (Week 0): At the end of screening period (Baseline visit, window period + 3 days), subjects fulfilling the rhinitis frequency and symptom criteria (baseline average scores as: average 24-h TNSS 10 over 15 days, and requiring no more than 2 tablets of rescue medication (Loratidine) daily to control the symptoms) will be randomized to one of the 3 treatment groups to receive the following treatment regimens:
- Group 1: E-RH-06/ 1 BID: (E-RH-06 + Placebo) Twice Daily
- Group 2: E-RH-06/ 2 BID: (E-RH-06 + E-RH-06) Twice Daily
- Group 3: Placebo: (Placebo + Placebo) Twice Daily Rescue medication accountability \& dispensing will be performed. Specially designed rescue medication charts will be dispensed. Subjects will be provided with subject diaries. Vitals \& general examination will be performed. TNS scoring will be performed. IP/ Placebo will be dispensed. IP accountability will be performed. Adverse event \& serious adverse event monitoring will be performed.
Days 14 (window period plus/ minus 3 days) (Follow Up I Visit): This visit will involve general examination \& vital signs recording. The frequency and intensity of symptoms as well as AE/SAE will be monitored and documented. IP/ placebo accountability \& dispensing will be conducted. Rescue medication accountability \& dispensing will be done. TNS scoring will be performed.
Day 28 (window period plus/ minus 3 days) (Follow Up II Visit): General examination, vital signs (Blood Pressure and Pulse) recording, documenting frequency and intensity of symptoms, monitoring of AE/SAE will be done. IP/ Placebo \& rescue medication accountability \& dispensing will be done. Subject diary will be assessed.
Day 56 (window period plus/ minus 3 days) (Follow Up III Visit): The visit will involve general examination \& vital signs recording, documenting of frequency and intensity of symptoms, monitoring of AE/SAE and use of rescue medication. IP/ Placebo accountability \& dispensing will be performed. Rescue medication will be dispensed for further usage. TNS scoring will be done.
Day 84 (window period plus/ minus 3 days) (End-of-Treatment Visit): General examination, vital signs recording, documenting frequency and intensity of symptoms, monitoring of AE/SAE will be performed. Dispensed IP/ Placebo \& rescue medication will be accounted in coordination with the left medication count, rescue medication chart \& patients history. TNS scoring will be performed. Placebo will be dispensed. Rescue medication will be dispensed to continue further. Blood sample will be collected for CBC, SGPT \& Serum Creatinine analysis. ECG will be performed.
Day 112 (window period plus/ minus 3 days) (Post Treatment Follow Up Visit): The visit will involve general examination, vital signs recording, documenting frequency and intensity of symptoms, monitoring of AE/SAE and use of rescue medication. Rescue medication accountability will be performed. TNS scoring will be performed.
In between the follow up clinic visits, weekly scores for intensity of rhinitis symptoms will be obtained through subject diaries /telephonic assessments made at each week.
Telephonic Follow Up: Telephonic follow up will be done on Day 42, 78 \& 90 to assess the nasal symptoms.
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. In case of more than/ equal to 75% subjects from individual active groups demonstrating significant sustained efficacy at week 16, the study will enter in to an open label, exploratory, extended follow-up phase for next 36 weeks (total 52 weeks). This extended follow-up phase will be conducted to determine if 12-week treatment with E-RH-06 help to reduce risk of seasonal nasal congestion with-or-without rhinorrhea during the extended follow-up period of 52-weeks. No other efficacy or safety evaluations will be carried out during this phase (extended follow-up).
- Conditions
- Chronic Rhinitis
- Being tested
- E-RH-06, Placebo
- Keywords
- Rhinitis
- Medical subject headings
- Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-RH-06Dietary supplement
Also called Olfaclear
Capsules, 1 capsule/ 2 capsule, twice daily for 12 weeks
PlaceboDietary supplement
1/ 2 capsules, twice daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| E-RH-06 - Low Dose | Experimental | 1 Capsule twice daily Receives: Dietary Supplement: E-RH-06 |
| E-RH-06 - High Dose | Experimental | 2 capsules twice daily Receives: Dietary Supplement: E-RH-06 |
| Placebo ; | Placebo comparator | Placebo Comparator Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (1)
Reduction of frequency
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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startOct 2011
- Primary completionMay 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Enovate Biolife Pvt Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Shalini Shrivastava, M.D, Study chair, Enovate Biolife Pvt Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01546662
- Sponsor's protocol ID
- EB-RH-02-11
- Other IDs
- EB-ERH-02-11
- Acronym
- EB-RH-02-11
- Status last verified
- Mar 2012
- First submitted
- 2 Mar 2012
- Last updated
- 7 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01546662
- Acronym / sponsor ID
- EB-RH-02-11 / EB-RH-02-11
- Conditions
- Chronic Rhinitis
- Keywords
- Rhinitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Enovate Biolife Pvt LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- May 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 7 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
Screening I (Day -14) Visit: After obtaining written informed consent, subjects will be screened for study eligibility as per the inclusion/exclusion criteria defined in the study protocol on screening visit. The screening evaluations will include general examination, medical history taking, recording of vital parameters and assessment of frequency of symptoms, and Total Nasal Symptom Score (TNSS) calculation. Blood sample will be collected for CBC, SGPT \& Urine creatinine analysis. Simultaneously urine samples will be collected for urine routine \& UPT analysis. ECG will be performed.
Screening II (Day -7) Visit: Laboratory results and ECG reports will be analysed by the investigator. Eligible subjects will be entered into 7 days run-in period. Rescue medication will be dispensed.
Baseline Visit/ Randomization Visit (Week 0): At the end of screening period (Baseline visit, window period + 3 days), subjects fulfilling the rhinitis frequency and symptom criteria (baseline average scores as: average 24-h TNSS 10 over 15 days, and requiring no more than 2 tablets of rescue medication (Loratidine) daily to control the symptoms) will be randomized to one of the 3 treatment groups to receive the following treatment regimens:
- Group 1: E-RH-06/ 1 BID: (E-RH-06 + Placebo) Twice Daily
- Group 2: E-RH-06/ 2 BID: (E-RH-06 + E-RH-06) Twice Daily
- Group 3: Placebo: (Placebo + Placebo) Twice Daily Rescue medication accountability \& dispensing will be performed. Specially designed rescue medication charts will be dispensed. Subjects will be provided with subject diaries. Vitals \& general examination will be performed. TNS scoring will be performed. IP/ Placebo will be dispensed. IP accountability will be performed. Adverse event \& serious adverse event monitoring will be performed.
Days 14 (window period plus/ minus 3 days) (Follow Up I Visit): This visit will involve general examination \& vital signs recording. The frequency and intensity of symptoms as well as AE/SAE will be monitored and documented. IP/ placebo accountability \& dispensing will be conducted. Rescue medication accountability \& dispensing will be done. TNS scoring will be performed.
Day 28 (window period plus/ minus 3 days) (Follow Up II Visit): General examination, vital signs (Blood Pressure and Pulse) recording, documenting frequency and intensity of symptoms, monitoring of AE/SAE will be done. IP/ Placebo \& rescue medication accountability \& dispensing will be done. Subject diary will be assessed.
Day 56 (window period plus/ minus 3 days) (Follow Up III Visit): The visit will involve general examination \& vital signs recording, documenting of frequency and intensity of symptoms, monitoring of AE/SAE and use of rescue medication. IP/ Placebo accountability \& dispensing will be performed. Rescue medication will be dispensed for further usage. TNS scoring will be done.
Day 84 (window period plus/ minus 3 days) (End-of-Treatment Visit): General examination, vital signs recording, documenting frequency and intensity of symptoms, monitoring of AE/SAE will be performed. Dispensed IP/ Placebo \& rescue medication will be accounted in coordination with the left medication count, rescue medication chart \& patients history. TNS scoring will be performed. Placebo will be dispensed. Rescue medication will be dispensed to continue further. Blood sample will be collected for CBC, SGPT \& Serum Creatinine analysis. ECG will be performed.
Day 112 (window period plus/ minus 3 days) (Post Treatment Follow Up Visit): The visit will involve general examination, vital signs recording, documenting frequency and intensity of symptoms, monitoring of AE/SAE and use of rescue medication. Rescue medication accountability will be performed. TNS scoring will be performed.
In between the follow up clinic visits, weekly scores for intensity of rhinitis symptoms will be obtained through subject diaries /telephonic assessments made at each week.
Telephonic Follow Up: Telephonic follow up will be done on Day 42, 78 \& 90 to assess the nasal symptoms.
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. In case of more than/ equal to 75% subjects from individual active groups demonstrating significant sustained efficacy at week 16, the study will enter in to an open label, exploratory, extended follow-up phase for next 36 weeks (total 52 weeks). This extended follow-up phase will be conducted to determine if 12-week treatment with E-RH-06 help to reduce risk of seasonal nasal congestion with-or-without rhinorrhea during the extended follow-up period of 52-weeks. No other efficacy or safety evaluations will be carried out during this phase (extended follow-up).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| E-RH-06 - Low Dose | Experimental | Dietary Supplement: E-RH-061 Capsule twice daily |
| E-RH-06 - High Dose | Experimental | Dietary Supplement: E-RH-062 capsules twice daily |
| Placebo ; | Placebo comparator | Dietary Supplement: PlaceboPlacebo Comparator |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E-RH-06Also: OlfaclearCapsules, 1 capsule/ 2 capsule, twice daily for 12 weeks | Dietary supplement | E-RH-06 - High Dose, E-RH-06 - Low Dose |
| Placebo1/ 2 capsules, twice daily for 12 weeks | Dietary supplement | Placebo ; |
Primary outcome
TNSS Score
Time frame: 12 weeks
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
1 secondary outcome
Reduction of frequency
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Shalini Shrivastava, M.D study chair
Enovate Biolife Pvt Ltd
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-RH-06 in people with Chronic Rhinitis, run by Enovate Biolife Pvt Ltd at 4 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TNSS Score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2012.