Clinical Study of Shatyadi Churna And Vasadi Kashaya With And Without Nitya Virechana In The Management Of Tamak Shwasa W.S.R. COPD

Phase 2

Completed

Conditions: Chronic obstructive pulmonary disease, unspecified,

Registration Number: CTRI/2020/09/027722

Lead Sponsor: National Institute of Ayurveda

Brief Summary: NEED OF STUDY: - Ayurveda has advocated Kapha-vata shamak and Vatanulomana chikitsa as line of treatment of Shwasa roga. - Shatyadi churna and Vasadi Kashaya have been selected for the present research work as both the trial drugs are Kapha-vata shamaka in nature and have potential to break or reverse the Samprapti of Shwasa roga. - Acharya Charaka has also indicated the Virechana in the treatment of Tamaka Shwasa. Hence it is planned to see whether addition of Virechana produces any significant difference in the treatment outcome. For the same Snighdha Nitya virechana is selected keeping in view the Alpabala and Pratiloma gati of Vata in the patients of Tamak Shwasa Roga w.s.r. to COPD.

Aims and Objectives 1. To assess the efficacy of Shatyadi Churna andVasadi Kashaya in the management of Tamaka Shwasa w.s.r.to COPD. 2. To assess whether administration of Nitya virechana causes any difference in the outcome of trial drug.

Research Problem:

i. Are Shatyadi churna and Vasadi kashaya effective in the management of Tamak Shwasa roga w.s.r. to COPD?

ii. Does Nitya virechana enhance the efficacy of the trial drugs?

HYPOTHESIS:

Null Hypothesis:

i. Shatyadi churna and Vasadi kashaya are not effective in the management of Shwasa roga w s.r. to COPD?

ii. Nitya virechana does not enhance the efficacy of the trial drugs. Alternate hypothesis:

i. Shatyadi kand Vasadi kashaya are effective in the management of Tamak Shwas roga w.s.r. to COPD?

ii. Nitya virechana enhance the efficacy of the trial drugs.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 40

Inclusion Criteria

Subjects willing to participate in this clinical trial.
Patients in the age group of 30 to 70 years of either sex.
Patients who have FEV1/FVC <0.7 on post bronchodilator spirometry.

Exclusion Criteria

Age below 30 and above 70years of age.
Patients suffering from Pulmonary Tuberculosis, Pleural effusion.
Patients suffering from Bronchiectasis.
Patient suffering from Bronchial Asthma.
Patients suffering from congestive heart failure.
Patients suffering from Bronchogenic carcinoma or other form of malignancies.
Status asthmaticus.
Patients with Haemoglobin less than 9 mg/dl.
Pregnant and lactating women.
Patients suffering from serious systemic disorders like Renal diseases, Ischemic heart Disease, Malignant Hypertension, uncontrolled Diabetes Mellitus.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in the sign & symptoms of Tamak Shwasa w.s.r. to COPD	30 days

Secondary Outcome Measures

Name	Time	Method
Changes in the pulmonary function test i.e. improvement in the PFT parameters	30 days

Trial Locations

Locations (1): NIA Hospital
🇮🇳
Jaipur, RAJASTHAN, India
NIA Hospital
🇮🇳Jaipur, RAJASTHAN, India
Dr Vikas Vikrant
Principal investigator
9340330486
drvk1980@gmail.com