| CTRI Number |
CTRI/2024/10/075549 [Registered on: 21/10/2024] Trial Registered Prospectively |
| Last Modified On: |
21/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A small scale clinical study to understand safety and effectiveness of Respikshar-Y25 in patient of Asthma. |
|
Scientific Title of Study
|
A pilot, exploratory clinical study to evaluate the safety and efficacy of Respikshar-Y25 tablet in the patients with 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 Mrudula V Joshi |
| Designation |
Head of Department (Ayurved Samhita evam Siddhant) |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research Centre, Pimpri, Pune-18 |
| Address |
Department of Ayurved Samhita and Siddhant, 4th floor, Dr. D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri-Chinchwad, Maharashtra, India 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9226279270 |
| Fax |
|
| Email |
mrudula.joshi@dpu.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mrudula V Joshi |
| Designation |
Head of Department (Ayurved Samhita evam Siddhant) |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research Centre, Pimpri, Pune-18 |
| Address |
Department of Ayurved Samhita and Siddhant, 4th floor, Dr. D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri-Chinchwad, Maharashtra, India 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9226279270 |
| Fax |
|
| Email |
mrudula.joshi@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vatsal L Dhudashiya |
| Designation |
P.G. Scholar |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research Centre, Pimpri, Pune-18 |
| Address |
Department of Ayurved Samhita and Siddhant, 4th floor, Dr. D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri-Chinchwad, Maharashtra, India 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9429882282 |
| Fax |
|
| Email |
vatsaldhudashiya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D.Y. Patil college of Ayurved and Research centre, Pimpri, Pune-18 |
|
|
Primary Sponsor
|
| Name |
Sudhatatva pharmacy |
| Address |
Dr DY Patil College Rd, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra, India 411018 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Mrudula V Joshi |
Dr. D. Y. Patil Ayurved hospital, Pimpri, Pune-18 |
Kayachikitsa OPD no. 05 (Ground floor) and Kayachikitsa male and female IPD (first floor)
Pune
MAHARASHTRA |
9226279270
mrudula.joshi@dpu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. DYPCA & RC INSTITUTIONAL ETHICS COMMITTEE PIMPRI, PUNE-18 |
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 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Respikshar-Y25, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 550(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: -warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with mild or moderate cases of Asthma irrespective of sex, aged between 18 years to 65 years will be considered.
History of Asthma less than 5 year.
Peak Expiratory flow rate more than 80 lit/min and less than 300 lit/min.
|
|
| ExclusionCriteria |
| Details |
Asymptomatic Asthma patients
Known case of other respiratory illness
The patients who had history of uncontrolled diabetes and uncontrolled systemic arterial hypertension, other systemic illness
Chronic cigarette smokers
Individuals with known allergies to ingredients of interventional drug
Pregnant or breastfeeding women
Patient in status asthmaticus |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe changes in Peak expiratory flow rate (PEFR) value after treatment in Asthma patients compared with base line values. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To observe changes in respiratory rate, Absolute Eosinophil Count, Erythrocyte Sedimentation Rate (ESR), Asthma control questionnaire (ACQ) and Asthma control test (ACT) questionnaire after treatment in Asthma patients compared with base line values. |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
01/11/2024 |
| 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="0"
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
|
The
selected intervention for this study, Respikshar-Y25, comprises a
polyherbomineral tablet formulation containing several key ingredients with purposeful therapeutic properties for management of Asthma.
INDICATIONS AND USES
Mild to moderate patients of Asthma STUDY OBJECTIVES
The proof-of-concept study presented here will be carried
out with the following objectives:
A.
Primary objective:
1.
To observe changes in Peak expiratory flow rate (PEFR)
value after treatment in Asthma patients compared with base line values.
B. Secondary objective:
1.
To observe changes in respiratory rate, Absolute
Eosinophil Count, Erythrocyte Sedimentation Rate (ESR), Asthma control questionnaire
(ACQ) and Asthma control test (ACT) questionnaire after treatment in Asthma patients compared with base line
values.
2. To observe the safety
of interventional drug.
STUDY DETAILS Screening visit (S1) At the screening visits, (S1) Informed Consent will be
taken and documentation of the same will be done. A detail interrogation for medical
history, Concomitant Medication or any changes will be documented. Pregnancy
Test (For Female subjects of child bearing potential) will be performed. Physical Examinations, Vital Signs (Blood
Pressure, Heart Rates, Temperature,
Respiratory rate, SpO2), Peak expiratory flow rate (PEFR) will be measured, Blood collection will be done for
the test Absolute eosinophil count and Erythrocyte
Sedimentation Rate (ESR). Asthma control questionnaire (ACQ) and Asthma
control test (ACT) questionnaire will be filled. Only for necessary
participants LFT, KFT and chest X-ray will be performed. For eligible patients
interventional drug, daily diary card and rescue medication will be provided. Active treatment period After the assessment, patients who fulfill all the
eligibility criteria will enter in 4 weeks active treatment period. Study
Medication, Daily diary Card and Rescue medication will be provided. Training
for how to fill the diary will be given. Follow up visits will be scheduled at 2nd
and 4th week after inclusion. Patients will be called accordingly. A
window period of ± 3 days will be allowed for each follow up visit. Visit T2: In this visit,
Vital
Signs will be checked. Detail physical examination will be done. Peak expiratory flow rate (PEFR) will be
measured. Asthma control questionnaire (ACQ) and Asthma control test (ACT) questionnaire will be filled. Blood collection will be
done for the test Absolute eosinophil count and Erythrocyte
Sedimentation Rate (ESR). Daily diary Card will be examined, Medication
compliance, use of rescue medication, concomitant medication will be checked. Adverse events if any will be recorded. Study
Medication till next follow up will be provided. Patients will be called for next visit after 2 weeks. Visit T4:
In this visit,
Vital
Signs will be checked. Detail physical examination will be done. Peak expiratory flow rate (PEFR) will be
measured. Asthma control questionnaire (ACQ) and Asthma control test (ACT) questionnaire will be filled. Daily diary Card will be examined, Medication compliance, use of rescue
medication, concomitant medication will be checked. Adverse events if
any will be recorded.
STUDY DURATON
The study duration will be total of 4 weeks after
being recruited in the study. The whole study will be completed in 6 months
period.
ASSESSMENT OF STUDY
Following efficacy and safety parameters will be used for
the assessment of the study.
EFFICACY ASSESSMENT:
·
Objective
assessment
measures:
1. Peak expiratory flow
rate (PEFR)
2. Respiratory rate
3. Oxygen saturation (SpO2)
4.
Absolute eosinophil
count
5.
Erythrocyte Sedimentation Rate (ESR)
6.
Chest X-ray (if necessary)
·
Subjective assessment measures:
1. Asthma control questionnaire (ACQ)
2. Asthma control test (ACT) questionnaire
SAFETY ASSESSMENT:
All the adverse events occurring throughout the
treatment course will be recorded and managed accordingly. The safety of the
patient will also be assessed by Changes in vital signs & clinically
significant laboratory changes (if necessary) at the end of treatment period
after administration on of treatment compared with baseline.
STATISTICAL ANALYSIS
Student’s paired ‘t’ test will be used, whereas
non-parametric data will be evaluated using Wilcoxan matched paired test.
P<0.05 will be considered as level of significance.
|