| CTRI Number |
CTRI/2024/10/074611 [Registered on: 01/10/2024] Trial Registered Prospectively |
| Last Modified On: |
29/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical Study On Bharangi Sarkara In Patients With Tamaka Shwasa(Bornchial Asthma) |
|
Scientific Title of Study
|
A Randomized Controlled Trial To Evaluate The Effect Of Bharangi Sarkara In Tamaka Shwasa W.S.R To Bronchial Asthma |
| 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 JYOTHSNAA K |
| Designation |
PG SCHOLAR |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre,Kuthpady |
| Address |
Department of Kayachikitsa Sri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre,Kuthpady
Udupi
KARNATAKA
574118
India |
| Phone |
8825928567 |
| Fax |
|
| Email |
kjyoth24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VEERAKUMARA K |
| Designation |
Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre,Kuthpady |
| Address |
Department of Kayachikitsa Sri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre,Kuthpady
Udupi
KARNATAKA
574118
India |
| Phone |
9743490753 |
| Fax |
|
| Email |
khadiravana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR JYOTHSNAA K |
| Designation |
PG SCHOLAR |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre,Kuthpady |
| Address |
Department of Kayachikitsa Sri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre,Kuthpady
Udupi
KARNATAKA
574118
India |
| Phone |
8825928567 |
| Fax |
|
| Email |
kjyoth24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre,Kuthpady, Udupi, Karnataka- 574118, India |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre,Kuthpady |
| Type of Sponsor |
Private medical college |
|
|
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 JYOTHSNAA K |
Sri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre,Kuthpady, Udupi |
OPD 7, Department of Kayachikitsa, Sri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre,Kuthpady, Udupi, Karnataka- 574118, India
Udupi
KARNATAKA |
8825928567
kjyoth24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Clearance Committee, Sri Dharmasthala Manjunatheshwara College of Ayurveda, Hospital and Research Centre,Kuthpady |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) 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: Tekaraja Churna, Reference: Sahasrayoga, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Honey), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: BHARANGI SARKARA , Reference: BHAISHAJYA RATNAVALI, Route: Oral, Dosage Form: Khanda /Granules, Dose: 10(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients fulfilling the diagnostic criteria.
2. Age eligibility for the study- 18 years to 70 years.
3. Mild intermittent, Mild persistent, Moderate persistent cases of Bronchial Asthma
according to GINA guidelines for Asthma |
|
| ExclusionCriteria |
| Details |
1. Severe persisting Asthma according to Global Initiative for Asthma (GINA) guidelines.
2. Patient with history of congenital anatomical abnormalities of chest and respiratory system.
3. Subjects with uncontrolled diabetes mellitus were excluded (RBS more than 300 mg/dl)
4. Other systemic disorders which intervene the treatment.
5. Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Teevra Vega Shwasa - Shwasa Krichrata (Dyspnoea)
2. Dukhena Kapha nissaranam (Expectoration)
3. Ghurghuratwam (Wheezing)
4. Kasa (Cough) |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Changes in Peak Flow Meter Test values
2. Chest Expansion (in centimeters): during inspiration and expiration
3. Sputum: Scanty/Moderate/Profuse |
30 days |
|
|
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 3 |
|
Date of First Enrollment (India)
|
24/10/2024 |
| 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="2"
Months="0"
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
|
This is a Randomized,open label,parallel
group study comparing the safety and efficacy of Trial drug [group-A] Bharangi Sarkara 10g daily and the Controlled drug [group-B] Tekaraja churna 12g daily for 30 days for 15
patients to each groups and will be conducted in Shri Dharmasthala Manjunatheshwara
college of Ayurveda and Hospital, Kuthpady,Udupi,
Karnataka, India. The Primary outcome measures will be assessed before and after the treatment using the Subjective parameters. The Secondary outcome measures will be assessed with objective parameteres like Peak flow meter test values, Chest expansion values, Sputum quantity before and after the treatment. Hence an effort has been planned
through this clinical study to planned through this clinical study to prove the efficacy of Bharangi Sarkara as effective against Tamaka Shwasa w.s.r to Bronchial Asthma.
|