The effect of Trikatu Churna and Trimada Churna in Pulmonary Function Test variation in Obese Patients

Phase 2/3

Not yet recruiting

• Conditions: Other obesity. Ayurveda Condition: Sthoulya,

• Registration Number: CTRI/2024/02/063062
• Lead Sponsor: RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES KARNATAKA BANGALORE

Brief Summary

This is a comparative clinical study which  is carried out in two groups and each group carries 30 patients. Group A - Trikatu Choorna and Group B - Trimada Choorna. PFT and Lipid Profile is assessed before and after the intervention.

Patients who visit BLDEAs AVS AMV Hospital IPD and OPD are randomly selected who fits in the inclusion criteria.

The diagnosed subject of Sthoulya will be evaluated by a detailed history and clinical examinations.

From this study we can evaluate the variations of the Pulmonary function and lipid profile in sthoulya subjects and to find the association between them.

Also to evaluate the effect of Trikatu Choorna and Trimada Choorna on both Pulmonary function test and Lipid Profile in Sthoulya with clinicla trial.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-06-10
• Study Start: 2024-04-29

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• •Patients diagnosed with clinical features of Sthoulya.
• • Body mass index should be more than 30.
• •Subjects signed on informed consent form.

Exclusion Criteria

• •Diagnosed with respiratory disorders.
• •Cardiac diseases •Diabetics and Hypertension.
• •Abnormal chest wall, Shape, Size •History of renal dysfunction.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Subjective Criteria:	Patient is assessed with the above said parameters on 90th day. The observation will be recorded in the proforma of case sheet. Follow up will be done after 1mn.
Symptoms mentioned in the Ayurvedic classical texts.	Patient is assessed with the above said parameters on 90th day. The observation will be recorded in the proforma of case sheet. Follow up will be done after 1mn.
•Udara Lambanam(Sagging of abdomen).	Patient is assessed with the above said parameters on 90th day. The observation will be recorded in the proforma of case sheet. Follow up will be done after 1mn.
•Shrama (Exhaustion)	Patient is assessed with the above said parameters on 90th day. The observation will be recorded in the proforma of case sheet. Follow up will be done after 1mn.
•Alpe ApiChestiteShwasam(Dyspnea/difficulty in breathing even with minimal strain)	Patient is assessed with the above said parameters on 90th day. The observation will be recorded in the proforma of case sheet. Follow up will be done after 1mn.
•Spik Lambanam(sagging of buttocks),	Patient is assessed with the above said parameters on 90th day. The observation will be recorded in the proforma of case sheet. Follow up will be done after 1mn.
•StananLambanam(Sagging of Breasts),	Patient is assessed with the above said parameters on 90th day. The observation will be recorded in the proforma of case sheet. Follow up will be done after 1mn.
Objective criteria	Patient is assessed with the above said parameters on 90th day. The observation will be recorded in the proforma of case sheet. Follow up will be done after 1mn.
•Anthropometricmeasurements-BMI, Waist hip circumference, Skin fold thickness	Patient is assessed with the above said parameters on 90th day. The observation will be recorded in the proforma of case sheet. Follow up will be done after 1mn.
•Pulmonary function test- Spirometry- To get the Pulmonary functionParameters like Residual Volume, Functional Residual volume, Tidal Volume, FEV1(Forced Expiratory Volume), FVC (Forced Vital Capacity), FEV1/FVC ratio, PEFR (Peak Expiratory Flow rate), MVV (Maximum Voluntary Ventilation).	Patient is assessed with the above said parameters on 90th day. The observation will be recorded in the proforma of case sheet. Follow up will be done after 1mn.
•Lipid profile	Patient is assessed with the above said parameters on 90th day. The observation will be recorded in the proforma of case sheet. Follow up will be done after 1mn.

Secondary Outcome Measures

Name	Time	Method
To know the effect of Trikatu choorna and Trimada choorna in sthoulya and observe any changes in PFT and Lipid Profile.	Patient is assessed with the above said parameters on 90th day. The observation will be recorded in the proforma of case sheet. Follow up will be done after 1mn.

Trial Locations

Locations (1)

BLDEAs avs ayurveda mahavidyalaya Hospital and Research Centre; 🇮🇳 Bijapur, KARNATAKA, India

BLDEAs avs ayurveda mahavidyalaya Hospital and Research Centre

🇮🇳Bijapur, KARNATAKA, India

Dr Shruti Hiremath

Principal investigator

9986970693

Shrutih2020@gmail.com