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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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CTRI |
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Last refreshed on:
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29 April 2024 |
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Main ID: |
CTRI/2024/04/065740 |
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Date of registration:
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16-04-2024 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A clinical trial to study the effect of a drug agastya haritaki in post COVID19 and non COVID 19 patients of tamaka shwas (Bronchial asthma)
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Scientific title:
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A comparative clinical study on the efficacy of Agastya Haritaki in post COVID-19 & non COVID-19 subjects of Tamaka shwas (Bronchial asthma) - NIL |
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Date of first enrolment:
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23-04-2024 |
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Target sample size:
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100 |
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Recruitment status: |
Not Yet Recruiting |
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URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=97234 |
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Study type:
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Interventional |
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Study design:
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Non-randomized, Multiple Arm Trial Method of generating randomization sequence:Not Applicable Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Not Applicable
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Phase:
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Phase 2/ Phase 3
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Countries of recruitment
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India
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Contacts
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Name:
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Shalini
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Address:
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Department of Kayachikitsa , Faculty Of Ayurveda, IMS, BHU
221005
Kolkata, UTTAR PRADESH
India |
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Telephone:
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9785520474 |
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Email:
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dr.shalini@bhu.ac.in |
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Affiliation:
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Institute of medical sciences, BHU |
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Name:
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Shalini
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Address:
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Department of Kayachikitsa , Faculty Of Ayurveda, IMS, BHU
221005
Kolkata, UTTAR PRADESH
India |
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Telephone:
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9785520474 |
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Email:
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dr.shalini@bhu.ac.in |
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Affiliation:
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Institute of medical sciences, BHU |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1.Patient with stable Bronchial Asthma (Tamaka shwasa) (as per WHO GINA Guideline) for at least 6 weeks prior to study entry.
2. Positive test of reversibility:
• Symptomatic patients - an improvement of 60 L/min or =20% in PEFR, 10 minutes after the inhalation of 200 mcg of Salbutamol.
• Asymptomatic patients - 60 L/min or =20% fall in PEFR by provocation with 5-10 minutes of physical exercise, followed by reversal upon inhalation of 200 mcg of Salbutamol, when assessed after 10 minutes.
3.Patient willing and able to participate for 16 weeks.
Exclusion criteria: 1. Patients with PEFR less than 50% and/ or FEV1 more than 50% of the predicted value.
2. Patients with evidence of malignancy.
3. Patients present with co-morbid disorders. (DM, TB, RA, Ca etc.).
Patient with poorly controlled Diabetes Mellitus (HbA1c more than10%).
4. Patients with poorly controlled Hypertension (i.e. Systolic more than 160 mm of Hg and Diastolic more than 100 mm of Hg)
5. Patients on prolonged ( more than 6 weeks) medication with corticosteroids, bronchodilators, mast cells stabilizers, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study.
6. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders, etc.)
7. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia .
8. Symptomatic patients with clinical evidence of Heart failure.
9. Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) more than 2 times upper normal limit) or Renal Disorders (defined as S. Creatinine more than1.2mg/dL), Severe Pulmonary Dysfunction, or any other condition that may jeopardize the study.
10. H/o hypersensitivity to the trial drug or any of its ingredients.
11. Pregnancy or lactating women.
12. Positive SARS-CoV-2 Real Time PCR or antigen in nasopharyngeal swab at screening visit.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Health Condition 1: J452- Mild intermittent asthma
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Primary Outcome(s)
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Change in the clinical symptoms (Asthma Control Questionnaire).Timepoint: 12 weeks
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Secondary Outcome(s)
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Change in the objectives/ laboratory parameters.Timepoint: 12 weeks
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Source(s) of Monetary Support
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Institute of Eminance, BHU, VARANASI
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Ethics review
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Status: Approved
Approval date: 20/10/2022
Contact:
Institutional Ethics Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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