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CTRI Number  CTRI/2020/08/027013 [Registered on: 07/08/2020] Trial Registered Prospectively
Last Modified On: 19/02/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Use of Roselle in Bronchial asthma and Malnutrition 
Scientific Title of Study   Clinical study to evaluate the Efficacy and safety of ROSELLE in patients with Bronchial asthma and Malnutrition. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr M Sakthi Balan 
Designation  Medical Consultant 
Affiliation  KI3, CRO 
Address  Department of medicine & Diabetology, Room no.1, Thirumalai Poly Clinic, and Raghavendra Diagnostic Centre. 153, Cuddalore main road, Mudaliarpet, Pondicherry

Pondicherry
PONDICHERRY
605004
India 
Phone  9443627722  
Fax    
Email  saheerose@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr M Sakthi Balan 
Designation  Medical Consultant 
Affiliation  KI3, CRO 
Address  Department of medicine & Diabetology, Room no.1, Thirumalai Poly Clinic, and Raghavendra Diagnostic Centre. 153, Cuddalore main road, Mudaliarpet, Pondicherry

Pondicherry
PONDICHERRY
605004
India 
Phone  9443627722  
Fax    
Email  saheerose@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr M Sakthi Balan 
Designation  Medical Consultant 
Affiliation  KI3, CRO 
Address  Department of medicine & Diabetology, Room no.1, Thirumalai Poly Clinic, and Raghavendra Diagnostic Centre. 153, Cuddalore main road, Mudaliarpet, Pondicherry

Pondicherry
PONDICHERRY
605004
India 
Phone  9443627722  
Fax    
Email  saheerose@gmail.com  
 
Source of Monetary or Material Support  
DXN Manufacturing India Pvt. Ltd. 141/4, 142/5, Whirpool road, Thiruvandar koil, Manadipet commune, Puducherry-605107 
 
Primary Sponsor  
Name  DXN Manufacturing India Pvt Ltd 
Address  141/4, 142/5, Whirpool road, Thiruvandar koil, Manadipet commune, Puducherry-605107  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sakthi Balan  Thirumalai Poly Clinic and Raghavendra Diagnostic Centre  Department of medicine & Diabetology, Room no.1, Thirumalai Poly Clinic, and Raghavendra Diagnostic Centre. 153, Cuddalore main road, Mudaliarpet, Pondicherry
Pondicherry
PONDICHERRY 		 9443627722

saheerose@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ki3  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J454||Moderate persistent asthma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  Not applicable 
Intervention  Roselle liquid syrup  Ingredients: Roselle juice, Suga, water, Antioxidants (Ascorbic acid). 30 ml mixed in 8 parts of water and taken orally after food once daily 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  Patients aged 18-59 years(both sex) suffering from mild and moderate-persistent bronchial asthma characterized by
-Daily symptoms of asthma
-Nocturnal awakenings more than once per week
-Daily need for SABAs for symptom relief
-More than just minor limitation in normal activity
-FEV1 between 60 and 80 percent of predicted and an FEV/FVC ratio less than the lower confidence interval for normal  
 
ExclusionCriteria 
Details  Patients with fever, drug-induced asthma, aspirin intolerance triad, asthma with fixed airflow limitation, asthma with obesity, late-onset asthma will be excluded.
-History of heart, liver, kidney, or other organ diseases;
-Allergy or intolerance to the individual constituents in NONIZHI
-Subjects who are pregnant and lactating mothers, or with any serious or invalidating other disease limiting full adhesion to the protocol.
-Participation in an investigational drug trial in the 30 days prior to the screening visit.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Evaluation of symptom scores & use of β-agonist, Pulmonary function tests and Absolute Eosinophil counts.

The effect of treatment on symptom scores will be evaluated by analysing average daily symptom scores of treatment on the basis of
3 categories: daytime symptoms, nocturnal symptoms, and allergic nasal and ocular symptoms. Each category will be scored 0 to 3, with a maximum possible score of 9. 		 week 4, 8 and 12 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluation of nutritional status using DETERMINE Your nutritional health
checklist questionnaire and BMI and mid arm circumference  		 week 4, 8 and 12 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
Final Enrollment numbers achieved (Total)= "12"
Final Enrollment numbers achieved (India)="12" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   10/08/2020 
Date of Study Completion (India) 01/12/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
The subjects who fulfilled the inclusion and exclusion criteria will be enrolled in the study. 
- The selected subjects will receive roselle liquid formulation 30 ml (mixed in 60ml warm water) orally once daily after food for 3 months.  
- The patients will be on standard treatment as well for bronchial asthma as per standard guidelines.
The Primary end points of this study will be:
 
Evaluation of symptom scores & use of β -agonist, Pulmonary function tests and Absolute Eosinophil counts.

The effect of treatment on symptom scores will be evaluated by analyzing average daily symptom scores at weeks 4, 8, and 12 of treatment on the basis of 3 categories: daytime
symptoms, nocturnal symptoms, and allergic nasal and ocular symptoms. Each category will be scored 0 to 3, with a maximum possible score of 9. 
The Secondary end points of this study will be: 

Evaluation of nutritional status using DETERMINE Your nutritional health checklist questionnaire and BMI and mid arm circumference will be monitored.
 
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