| CTRI Number |
CTRI/2024/05/068155 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
30/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of Unani Medicine in Bronchial Asthma |
|
Scientific Title of Study
|
Efficacy of Habb-e-Zeequn Nafas versus inhaler (Budesonide-formoterol DPI) in Bronchial Asthma: A randomized controlled study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shabbir Hasan |
| Designation |
PG SCHOLAR |
| Affiliation |
National Institute of Unani Medicine, Kottigepalya, Magadi main road Bangalore KARNATAKA |
| Address |
Department of Moalajat
National Institute of Unani Medicine, Kottigepalya, Magadi main road Bangalore KARNATAKA 560091 India
Department of Moalajat
National Institute of Unani Medicine, Kottigepalya, Magadi main road Bangalore KARNATAKA 560091 India
Bangalore
KARNATAKA
560091
India |
| Phone |
9039821252 |
| Fax |
|
| Email |
shabbirhasan.999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Mohd Aleemuddin Quamri |
| Designation |
Prof and HoD |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department of Moalajat, National Institute of Unani Medicine, Magadi main road, Kottigepalya, Bengaluru, Karnataka, 560091 INDIA
Magadi main road, Kottigepalya, Bengaluru, Karnataka, 560091 INDIA
Bangalore
KARNATAKA
560091
India |
| Phone |
9341072974 |
| Fax |
|
| Email |
drmaquamri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Mohd Aleemuddin Quamri |
| Designation |
Prof and HoD |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department of Moalajat, National Institute of Unani Medicine, Magadi main road, Kottigepalya, Bengaluru, Karnataka, 560091 INDIA
Magadi main road, Kottigepalya, Bengaluru, Karnataka, 560091 INDIA
Bangalore
KARNATAKA
560091
India |
| Phone |
9341072974 |
| Fax |
|
| Email |
drmaquamri@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Unani Medicine, Kottigepalya Magadi Main Road Bangalore Karnataka 560091 |
|
|
Primary Sponsor
|
| Name |
National Institute of Unani Medicine |
| Address |
Magadi main road, Kottigepalya, Bengaluru, Karnataka, 560091 INDIA. |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shabbir Hasan |
National Institute of Unani Medicine |
Department Of Moalajat OPD 1 and 2 and IPD.
Bangalore
KARNATAKA |
9039821252
shabbirhasan.999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(IEC) for Biomedical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J454||Moderate persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Habb-e-Zeequn Nafas |
Habb will be given orally, daily in a single dose of 53mg for 30 days. |
| Comparator Agent |
Inhaler (Budesonide-formoterol DPI) |
Metered dose (mcg): 200/6 (1 inhalation whenever needed) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1) Age between 18-50 years.
2) All gender.
3) Bronchial asthma of mild (FEV1 more than 70%) to moderate severity
(FEV1 60-69%) of predicted.
4) Patients ready to give consent for the study
|
|
| ExclusionCriteria |
| Details |
1) Patients below 18 and above 50 years of age.
2) FEV1 less than 60% of predicted in spirometry.
3) Patients with systemic illness such as HTN, IHD, DM, Thyroid disorders, etc.
4) Patients with a history of allergic rhinitis, emphysema, chronic bronchitis, pneumonia, pneumoconiosis, pulmonary tuberculosis.
5) Severe anemia.
6) Pregnant and lactating women.
7) Patients who had received corticosteroids, bronchodilators or CAM therapy within 2 weeks prior to enrollment.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in FEV1, FEV1/FVC ratio, PEF assessed by Spirometry |
0th, 15th, and 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Asthma Control Test score |
0th, 15th,and 30th day |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
24/06/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
42
diagnosed cases of Bronchial Asthma will be included in the study. Subjects will be randomly
allocated into two equal groups. Written informed consent will be obtained from
them. In test group, research drug (53mg) will be given in tablet form daily for
30 days. In the control group, control inhaler will
be advised according to GINA guidelines. Patients will be followed at 15th
and 30th day. Patient Between the age group 18-50 years of All genders, diagnosed with Bronchial Asthma of mild (FEV1 more than 70%) to moderate severity (FEV1 60-69%).
Main Outcome Measures:
Primary outcome: · Improvement in FEV1, FEV1/FVC ratio in response to the treatment.
Secondary outcome: Improvement in ACT (Asthma Control Test) score in response to the treatment.
|