A CLINICAL STUDY TO SEE THE EFFECT OF VASAVLEHA IN THE TREATMENT OF STABLE CHRONIC BRONCHITIS (JEERNA KASA)

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/06/004704
• Date of registration: 25-06-2014
• Prospective Registration: Yes
• Primary sponsor: Central Council for Research in Ayurvedic Sciences
• Public title: A CLINICAL STUDY TO SEE THE EFFECT OF VASAVLEHA IN THE TREATMENT OF STABLE CHRONIC BRONCHITIS (JEERNA KASA)
• Scientific title: CLINICAL EVALUATION OF VASAVLEHA IN THE MANAGEMENT OF STABLE CHRONIC BRONCHITIS - Nil
• Date of first enrolment: 01-07-2014
• Target sample size: 126
• Recruitment status: Closed to Recruitment of Participants
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=9323
• Study type: Interventional
• Study design: Single Arm Trial; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
• Phase: Phase 3

Countries of recruitment

India

Contacts

• Name: Dr Subhash singh
• Affiliation: M.S. Ayurveda Central Research Institute

• Name: Dr Subhash singh
• Affiliation: M.S. Ayurveda Central Research Institute

Key inclusion & exclusion criteria

Inclusion criteria: 1. Patients of either sex aged between 16 to 70 years.

2. Patient with history of uncomplicated Chronic Bronchitis (Chronic Bronchitis is defined as a cough that occurs every day with sputum production that lasts for at least three months, two years in a row).

3. Patient willing and able to participate in the study for 14weeks


Exclusion criteria: 1. Patients suffering from Acute Bronchitis.

2. Patients having PEFR < 50% of the predicted value.

3. Other pulmonary diseases like Emphysema, Cor pulmonale, Cyanosis, Pneumonia, Asthma, Cystic fibrosis, Tuberculosis, Lung cancer etc.

4. Patients with uncontrolled Diabetes Mellitus (Blood Sugar Fasting > 250mg/dl)

5. Patients with poorly controlled Hypertension ( >160/100mm of Hg)

6.Patients on prolonged ( > 6 weeks) medication with corticosteroids,bronchodilators, mast cell stabilizers, anti-depressants,

anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study.

7. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro - Endocrinal disorders, etc.)

8. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.

9. Symptomatic patients with clinical evidence of Heart failure.

10. Patients with concurrent serious hepatic disorders (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 2 times upper normal limit) or Renal Disorders (defined as S. Creatinine >1.2mg/dL).

11. Alcoholics and/or drug abusers.

12. H/o hypersensitivity to the trial drug or any of its ingredients.

13. Patients who have completed participation in any other clinical

trial during the past six (06) months.

14. Pregnant or lactating women

15. Any other condition which the Investigator thinks may jeopardize the study.



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Stable Chronic Bronchitis

Intervention(s)

Intervention1: Vasavleha: Vasavleha
Dose :10gm twice daily
Dosage Form: Avaleha
Route of Administration: Oral
Time of Administration:Twice a day after food
Anupana: Water
Packing Form:300gm jar
Duration of therapy: 12 weeks

Control Intervention1: Nil: Nil

Primary Outcome(s)

Change in clinical symptoms of chronic bronchitis.Timepoint: 14th day, 28th day, 42nd day, 56th day, 70th day and 84th day and after 2 weeks of follow up study.

Secondary Outcome(s)

Change in St. Georgeâ??s Respiratory Questionnaire (SGRQ) scores

Any acute exacerbations of Bronchitis occuring during the trial period.

Timepoint: 14th day, 28th day, 42nd day, 56th day, 70th day and 84th day and after 2 weeks of follow up study

Secondary ID(s)

NIL

Source(s) of Monetary Support

Support in terms of infrastructural facilities: 1. Ayurveda Central Research Institute (ACRI), Jaipur 2. Ayurveda Mental Health Research Institute, Nagpur. 3. National Ayurveda Research Institute for Vector Borne diseases, Vijayawada

Ethics review

Status: Approved
Approval date: 30/01/2014
Contact:

Institutional Ethics Committee, M.S. Ayurveda Central Research Institute, Jaipur

Status: Approved
Approval date: 26/03/2014
Contact:

Institutional Ethics Committee, Ayurveda Mental Health Research Institute, Nagpur

Status: Approved
Approval date: 28/03/2014
Contact:

Institutional Ethics Committee, National Ayurveda Research Institute for Vector Borne Diseases, Vijayawada