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CTRI Number  CTRI/2011/12/002185 [Registered on: 02/12/2011] Trial Registered Retrospectively
Last Modified On: 09/04/2012
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical study to evaluate efficacy of investigational product E-RH-06 at 2 dose levels for the management of chronic or recurrent rhinitis. 
Scientific Title of Study   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 rhinorr-hea. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
EB-ERH-02-11  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  shalini srivastava 
Designation  senior manager 
Affiliation  Enovate Biolife Pvt Ltd 
Address  203, Morya Landmark 1, Off New Link Road, Andheri West

Mumbai (Suburban)
MAHARASHTRA
400053
India 
Phone    
Fax    
Email  shalini@enovatebiolife.com  
 
Details of Contact Person
Scientific Query  
Name  shalini srivastava 
Designation  senior manager 
Affiliation  Enovate Biolife Pvt Ltd 
Address  203, Morya Landmark 1, Off New Link Road, Andheri West

Mumbai (Suburban)
MAHARASHTRA
400053
India 
Phone    
Fax    
Email  shalini@enovatebiolife.com  
 
Details of Contact Person
Public Query  
Name  shalini srivastava 
Designation  senior manager 
Affiliation  Enovate Biolife Pvt Ltd 
Address  203, Morya Landmark 1, Off New Link Road, Andheri West

Mumbai (Suburban)
MAHARASHTRA
400053
India 
Phone    
Fax    
Email  shalini@enovatebiolife.com  
 
Source of Monetary or Material Support  
Enovate Biolife Pvt Ltd 
 
Primary Sponsor  
Name  Enovate Biolife Pvt Ltd 
Address  203, Morya Landmark 1, Off New Link Road Andheri (West), Mumbai 400053, India  
Type of Sponsor  Other [Nutraceutical Company] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sanjay Palimkar  Shree Siddhi Clinic  Shop no 01, samta nagar, Khan compound, S.M. Dubey road, Raval Pada, Dahisar East.
Mumbai
MAHARASHTRA 		 9821118227
-
drsmpalimkar@yahoo.in 
Dr Rajesh Kewalramani  The clinic  Shop No-16, Bldg.No.13-A, Shanti Niketan,Kandarpada, Dahisar(West)
Mumbai
MAHARASHTRA 		 9820024766
-
rajeshtarna@hotmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
MEET Ethics Committee (Mumbai)-Dr. kailash rathi  Approved 
MEET Ethics Committee (Mumbai)-Dr. Kevalramani  Approved 
MEET Ethics Committee (Mumbai)-Dr. Palimkar  Approved 
MEET Ethics Committee (Mumbai)-Dr.Anirban Bandopadhyay  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  chronic or recurrent, non-infective nasal congestion with-or-without rhinorrhea,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  E-RH-06  Properiatary blend of Emblica officinalis, Tinospora cordifolia, Capparis spinosa, Aloe vera, Piper longum and Zinc. Recommended in dose of 1to 2 capsules BD orally for 12 weeks.  
Comparator Agent  Placebo  Inert substance for minimizing the bais. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  • 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 visit 
 
ExclusionCriteria 
Details  • 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 de-viated 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.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
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  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  
Outcome  TimePoints 
 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
 		 4 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/07/2011 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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:

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:

1.      Group 1: E-RH-06/ 1 BID: (E-RH-06 + Placebo) Twice Daily

2.      Group 2: E-RH-06/ 2 BID: (E-RH-06 + E-RH-06) Twice Daily

3.      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).  
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