| CTRI Number |
CTRI/2025/02/080901 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of Bharangyadi Kashaya in the dose of 50ml twice a day in comparison with Nidhigdikadi Kashaya in the dose of 50ml twice a day in the management of Bronchial Asthma in adults aged 18-60 years for a period of 30 days. |
|
Scientific Title of Study
|
To study the efficacy of Bharangyadi Kashaya in comparison with Nidhigdikadi Kashaya in Tamaka Swasa, Bronchial Asthma: A controlled randomized clinical 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 B Sanjuktha Shree |
| Designation |
Post Graduate Scholar Department of Kayachikitsa |
| Affiliation |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bangalore |
| Address |
Department of Kayachikitsa OPD Number.1,2,3,18,27, Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH 17 Anchepalya,Kumbalgodu post, Bangalore- 560074, Karnataka, India
Bangalore
KARNATAKA
560074
India |
| Phone |
9566225866 |
| Fax |
|
| Email |
bsanjuktha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Sharma M |
| Designation |
Associate Professor |
| Affiliation |
Shri Dharmasthala Manjunatheshwara Institute |
| Address |
Department of Kayachikitsa OPD Number-01 Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH 17 Anchepalya,Kumbalgodu post, Bangalore- 560074, Karnataka, India
Bangalore
KARNATAKA
560074
India |
| Phone |
9964022654 |
| Fax |
|
| Email |
drsharmamysr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr B Sanjuktha Shree |
| Designation |
Post Graduate Scholar Department of kayachikitsa |
| Affiliation |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bangalore |
| Address |
Department of Kayachikitsa OPD Number.1,2,3,18,27, Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH 17 Anchepalya,Kumbalgodu post, Bangalore- 560074, Karnataka, India
Bangalore
KARNATAKA
560074
India |
| Phone |
9566225866 |
| Fax |
|
| Email |
bsanjuktha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kayachikitsa OPD Number.1,2,3,18,27, Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH 17 Anchepalya,Kumbalgodu post, Bangalore- 560074, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Dr B Sanjuktha Shree |
| Address |
Department of Kayachikitsa OPD Number.1,2,3,18,27, Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH 17 Anchepalya,Kumbalgodu post, Bangalore- 560074, Karnataka, India |
| Type of Sponsor |
Other [self] |
|
|
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 B Sanjuktha Shree |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bangalore |
Department of Kayachikitsa OPD Number.1,2,3,18,27, Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, SH 17 Anchepalya,Kumbalgodu post, Bangalore- 560074, Karnataka, India
Bangalore
KARNATAKA |
9566225866
bsanjuktha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Shri Dharmasthala Manjunatheshwara Ayurveda and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J452||Mild intermittent asthma. Ayurveda Condition: TAMAKASVASAH, (2) ICD-10 Condition:J453||Mild persistent asthma. Ayurveda Condition: TAMAKASVASAH, (3) ICD-10 Condition:J454||Moderate persistent asthma. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Nidhigdikadi Kashaya, Reference: Sharangadhara Samhita- Madhyama Khanda- Kwatha Kalpana- Sloka 46-47, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bharangyadi Kashaya, Reference: Basavarajeeyam - Ashtama Prakarana- Swasa chikitsa- Sloka 206, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects fulfilling the diagnostic criteria of Tamaka Swasa.
2.Subjects having peak expiratory flow rate greater than 50 percentage of predicted value of Peak Expiratory Flow Rate chart.
3.Subjects within the age group of 18 to 60 years.
4.Chronicity less than or equal to 10 years. |
|
| ExclusionCriteria |
| Details |
1.Acute condition of Bronchial Asthma, Status asthmaticus.
2.Subjects suffering from associated diseases like Tuberculosis, pneumonia, Cardiac diseases, Uncontrolled Diabetes mellitus, Uncontrolled Hypertension.
3.Subjects having peak expiratory flow rate less than 50 percentage of predicted value of Peak Expiratory Flow Rate chart.
4.Subjects who are on corticosteroids.
5.Chronicity of more than 10 years.
6.Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in peak Expiratory Flow Rate and Absolute Eosinophil count in patients diagnosed with Tamaka Swasa.
|
0th day (Baseline), 15th day, 30th day and 45th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvements in reduction of signs and symptoms in patients diagnosed with Tamaka Swasa based on Asthma Control Questionnaire |
0th day (Baseline), 15th day, 30th day and 45th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| 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 Yet Recruiting |
| 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
|
A controlled clinical study on the efficacy of Bharangyadi
Kashaya in the management of Tamaka Swasa (Bronchial Asthma) in adults of age
group 18-60 years for a period of 30 days. During this study period 30 subjects
diagnosed with Tamaka Swasa (Bronchial Asthma) will be recruited and divided
into two groups, Group A (Trial drug/Intervention group) and Group B (Control
drug/Comparator group)15 subjects in each group respectively. Group A (Trial
drug/Intervention group) includes 15 subjects qualifying inclusion criteria of
the current study who will be administered Bharangyadi Kashaya internally in
the dose of 50ml in the morning after food for 30days starting from
day-01 of trial, assessment of the patient during trial on 0th day(baseline),
15th day, 30th day and after trial follow up on 45th day. Group B (Control
Drug/Comparator Group) it includes 15 subjects qualifying inclusion criteria of
the current study will be administered Nidhigdikadi Kashaya internally in the
dose of 50ml in the morning after food for 30days starting from day-01 of
trial,assessment of the patient during trial on 0th day(baseline), 15th day,
30th day and after trial follow up on 45th day. Primary outcome will be
the Improvement in Peak Expiratory Flow Rate and Absolute Eosinophil count
after 30 days in patients with Tamaka Swasa. The secondary outcome measure will
be improvement noticed in the reduction of signs and symptoms based on Asthma
Control Questionnaire after 30 days in patients with Tamaka Swasa.Statistical
analysis will be done through data obtained based on, before and after
treatment assessment. |