| CTRI Number |
CTRI/2021/11/038335 [Registered on: 30/11/2021] Trial Registered Prospectively |
| Last Modified On: |
07/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to Assess the Efficacy and Safety of H-15 Soft Gel Capsules and Sallaki tablets in Comparison with Standard of Care treatment in Patients Suffering from Mild to Moderate Bronchial Asthma |
|
Scientific Title of Study
|
An Open Label, Randomized, Parallel, Multi-center, Five-Arm, Comparative Clinical Study to Assess the Efficacy and Safety of H-15 (Boswellia serrata) Soft Gel Capsules and Sallaki tablets 400 mg in Comparison with Standard of Care (SOC) in Patients Suffering from Mild to Moderate Bronchial Asthma |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| GB_BS_001_21 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sailee Kadam |
| Designation |
AGM Medical Services |
| Affiliation |
Gufic Biosciences Limited |
| Address |
SM House 11 Sahakar Road Vile Parle East Mumbai Maharashtra
Mumbai MAHARASHTRA 400057 India
Mumbai
MAHARASHTRA
400057
India |
| Phone |
9869350948 |
| Fax |
|
| Email |
dr.sailee.kadam@guficbio.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sailee Kadam |
| Designation |
AGM Medical Services |
| Affiliation |
Gufic Biosciences Limited |
| Address |
SM House 11 Sahakar Road Vile Parle East Mumbai Maharashtra
Mumbai MAHARASHTRA 400057 India
Osmanabad
MAHARASHTRA
400057
India |
| Phone |
9869350948 |
| Fax |
|
| Email |
dr.sailee.kadam@guficbio.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Vairamuthu Ammaiyappan |
| Designation |
Associate Director Project Management |
| Affiliation |
iDD Research Solutions Pvt Ltd |
| Address |
Tek Meadows Campus No 51 3rd C block Old Mahabalipuram Rd
Sholinganallur Chennai Chennai TAMIL NADU 600119 India
Chennai
TAMIL NADU
600119
India |
| Phone |
9606829331 |
| Fax |
|
| Email |
vairamuthu.ammaiyappan@iddresearch.com |
|
|
Source of Monetary or Material Support
|
| Gufic Biosciences Limited
SM House 11 Sahakar Road Vile Parle East Mumbai Maharashtra Mumbai MAHARASHTRA 400057 India |
|
|
Primary Sponsor
|
| Name |
Gufic Biosciences Limited |
| Address |
SM House 11 Sahakar Road Vile Parle East Mumbai Maharashtra
India 400057 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Upendra Kumar |
Excel Hospital |
#1-5-56/29, Oldalwal Near IG Statue, Bandabasti, Alwal, Secunderbad-500010, India
Hyderabad
TELANGANA |
7731030321
doctorresearch1212@gmail.com |
| Dr Ravindra Sarnaik |
Leela Mores Chest Clinic |
Room no: 1, Clinical research Department, No57, North Avenue, Bhivapurkar Marg, Opp. Dhantoli Park main gate, Dhantoli, Nagpur 440012, Maharashtra, India
Nagpur
MAHARASHTRA |
9823037684
lmccnagpur@yahoo.com |
| Dr Dinesh S |
Medstar Speciality Hospital |
#641/17/1/3, Kodigehalli Main Road, Sahakarnagar, Bangalore-560092, Karnataka, India
Bangalore
KARNATAKA |
9886125229
medstarclinicalresearch@gmail.com |
| Dr Vijay Warad |
Sai Netralaya and Speciality Clinic |
Room no:10, Research Department, 102, A2 Wings, Arneshwar Park Phase II, Sahkar Nagar, Pune 411009, India
Pune
MAHARASHTRA |
9822436184
vijaywarad@gmail.com |
| Dr Avinash Gandhare |
Suretech Hospital |
Room No: 04, Clinical Research Department, 13A, Banerjee Marg, Dhantoli, Nagpur, 440012, Maharashtra, India
Nagpur
MAHARASHTRA |
8275556521
argandhare@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Excel Hospital Institutional Ethics Committee |
Approved |
| Medstar Speciality Hospital Ethics Committee |
Approved |
| Nagpur Independent Ethics Committee |
Approved |
| Nagpur Independent Ethics Committee |
Approved |
| Royal Pune Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J980||Diseases of bronchus, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
H-15 soft gel capsule |
500 mg once daily after meals with SOC |
| Intervention |
H-15 soft gel capsule |
500 mg Thrice daily after meals with SOC |
| Intervention |
H-15 soft gel capsule |
500 mg twice daily after meals with SOC |
| Intervention |
Sallaki 400mg tablet |
One tablet thrice daily consecutively for eight weeks is the duration of therapy. |
| Comparator Agent |
Standard of Care |
SOC treatment will be given as
per the treating investigator |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Male/female of ≥18 and ≤60 years of age
2.Patient who can and willing to provide written Informed Consent
3.Patient with an established diagnosis of mild to moderate bronchial asthma (FEV1 between 60 and 80%)
4.Patient with mild asthma under the treatment with low dose of Inhaled Corticosteroids (ICS) ICS-formoterol alone and patients with moderate asthma under the treatment of low or medium dose ICS-LABA (Long-Acting Beta-Agonist)
5.Patient with ACT (Asthma control test) score ˃19
6.Female of childbearing potential must have a negative pregnancy test and be non-lactating at screening visit
7.Patient/ patient’s legally acceptable representative understands and can comply with clinical trial protocol requirements
|
|
| ExclusionCriteria |
| Details |
1.Patient ˂ 18 or ˃ 60 years of age
2.Pregnant and/or nursing woman
3.Patient with severe or unstable bronchial asthma or having acute asthmatic attack at the time of enrolment
4.Patient with a clinically relevant respiratory tract infection in the four weeks prior to enrolment
5.Patient with any other clinically significant illness
6.Patient with a history of hypersensitivity to any of the components of the study medications
7.Patient who has participated in another trial with an investigational drug within 1 month prior to this trial.
8.Patients who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in FEV1 as measured by Spirometry (pulmonary function test)
Degree of improvement
Change in investigator’s diagnosed clinical symptoms like cough, wheezing, dyspnea and frequency of night attacks
|
From Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 0) at Visit 5, End of study (Day 60) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in force vital capacity (FVC)
Change in Asthma Control Test (ACT) score
Reduction in episodes of exacerbation
Change in Asthma Quality of Life Questionnaire (AQLQ) score
Change in Complete Blood Count (CBC), eosinophil count and Erythrocyte Sedimentation Rate (ESR) counts
Change in Liver Function Tests (LFTs) parameters, Blood Urea Nitrogen (BUN) level and Creatinine level
Number of incidences of Short-Acting Beta-Agonists (SABA) requirement during the study period
Number of Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE)
|
from Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 0) at Visit 5, End of study (Day 60) |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
30/11/2021 |
| 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="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
110 patients with mild to moderate Bronchial Asthma will be included in this study. Patients will be enrolled into the study based on Inclusion & Exclusion Criteria, patient history, and safety measures. The duration of each patient’s participation in the study will be of approximately 60 days. There will be total 05 visits during the study.
Treatment Arm 1: Control group on SOC (Standard of care) Treatment Arm 2: Sallaki tablets 400 mg thrice daily after meals with SOC Treatment Arm 3: BS Soft gel capsule 500mg once daily after meals with SOC Treatment Arm 4: BS Soft gel capsule 500mg twice daily after meals with SOC Treatment Arm 5: BS Soft gel capsule 500 mg thrice daily after meals with SOC
Patients will be visiting site every 15 days for Visit 2, Visit 3, Visit 4 and Visit 5. Following assessments will be done during these visits: · Physical examination including vital signs (B.P, body temperature, pulse rate, respiration rate) · Forced Expiratory Volume in one second (FEV1) · Peak expiratory flow rate (PEFR) · Force vital capacity (FVC) · Assessment of number of episodes of exacerbation · Asthma Quality of Life Questionnaire (AQLQ)
All patients will undergo clinical laboratory tests for safety at Baseline Day 0 and Visit 5, End of study visit (Day 60) |