| CTRI Number |
CTRI/2016/10/007376 [Registered on: 17/10/2016] Trial Registered Prospectively |
| Last Modified On: |
08/08/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Role of Herbs in the Management of Asthma |
|
Scientific Title of Study
|
Role of Breathe Free® in the Management of Bronchial Asthma- A Randomized Placebo Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| OI-004-2016 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Alben Sigamani |
| Designation |
Group Head Clinical Research |
| Affiliation |
Narayana Hrudayalaya Hospital |
| Address |
1st Floor, B Block, Narayana Health City, Bommasandra Industrial Area, Bangalore 560099, Karnataka State, INDIA
Bangalore
KARNATAKA
560099
India |
| Phone |
8884431444 |
| Fax |
|
| Email |
alben.sigamani.dr@nhhospitals.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjaya Chauhan |
| Designation |
Clinical Research Associate |
| Affiliation |
Organic India |
| Address |
Organic India Private Limited – R&D
8th Floor, A Block, Mazumdar Shaw Cancer Centre
Narayana Health City, Bommasandra Industrial Area
Bangalore 560099, Karnataka State, INDIA
Bangalore
KARNATAKA
560099
India |
| Phone |
9611252350 |
| Fax |
|
| Email |
drsanjayachauhan49@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sindhu N |
| Designation |
Ayurvedic Clinical investigator |
| Affiliation |
Organic India |
| Address |
Organic India Private Limited – R&D
8th Floor, A Block, Mazumdar Shaw Cancer Centre
Narayana Health City, Bommasandra Industrial Area
Bangalore 560099, Karnataka State, INDIA
Bangalore
KARNATAKA
560099
India |
| Phone |
99002643747 |
| Fax |
|
| Email |
reddysindhu993@gmail.com |
|
|
Source of Monetary or Material Support
|
| Organic India Private Limited – R&D 8th Floor, A Block, Mazumdar Shaw Cancer Centre Narayana Health City, Bommasandra Industrial Area Bangalore 560099, Karnataka State, INDIA |
|
|
Primary Sponsor
|
| Name |
Organic India |
| Address |
Organic India Private Limited – R&D 8th Floor, A Block, Mazumdar Shaw Cancer Centre Narayana Health City, Bommasandra Industrial Area Bangalore 560099, Karnataka State, INDIA |
| Type of Sponsor |
Other [Herbal Supplement Manufacturer] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sandeep Kumar Gupta |
KRM Hospital and Research Centre |
3/92-93, Vijayant Khand, Gomti Nagar, Lucknow-226010, Uttar Pradesh , India
Lucknow
UTTAR PRADESH |
7007208089
krmhrclko@gmail.com |
| Dr Alben Siagamani |
Mazumdar Shaw Medical Centre, Narayana Health |
Department of Clinical Research, 1st Floor, B Block, Narayana Health City, Bommasandra Industrial Area, Bangalore 560099, Karnataka State, INDIA
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
8884431444
alben.sigamani.dr@nhhospitals.org |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for KRM Hospital and Research Centre |
Approved |
| Narayana Health Medical Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Bronchial Asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Active poly herbal capsule and Formoterol/Fluticasone Single Maintence and Reliever therapy(SMART) therapy |
Each poly herbal contains four herbs: Inula racemosa, Ocimum sanctum, Terminalia Belerica and Piperum longum. All the participants will be instructed to take 2 capsules twice daily at a fixed time for 6 months. This will be used as add on therapy along with Formoterol/Fluticasone SMART therapy |
| Comparator Agent |
Placebo capsule and Formoterol/Fluticasone conventional therapy |
Inactive similar looking capsules.All the participants will be instructed to take 2 capsules twice daily at a fixed time for 6 months. This will be used as add on therapy along with Formoterol/Fluticasone conventional therapy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults aged ≥ 18 years.
2. History of asthma documented by a physician for at least 6 months
3. Patients on steroid therapy for at least 4 weeks.
4. If not on steroid therapy, patient and physician must be willing for 4 weeks run in on steroid therapy.
5. The subject agrees to participate in the study |
|
| ExclusionCriteria |
| Details |
Any one of the following
1. Acute illness (such as cold, flu, etc.) within one week before the administration of study drug
2. Abnormal hepatic and renal function
3. Pregnant, attempting to conceive, or lactating women
4. Current or former employees of organic India
5. Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days.
6. Physician uncomfortable with patient compliance to treatments or follow up.
7. Non-compliance to tobacco cessation therapy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Number of patients with 15% increase in forced expiratory volume(FEV1) from baseline
2. Number of patients with 50 L/min peak expiratory flow rate(PEFR) from baseline |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Frequency of asthma exacerbation per week |
6 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/11/2016 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Herbal therapy is the third most popular choice of adults suffering from asthma among complementary and alternative therapy. The aim of this trial is to study the effect of a poly herbal capsule containing fours herbs: Inula racemosa, Ocimum sanctum, Terminalia belerica and Piperum longum in the treatment of bronchial asthma.
Herbal therapy will be used as add on therapy to the standard therapy. |