A Comparative Clinical Study to Evaluate the Effect of Trikatu Choorna and Trimada Choorna in the Sthoulya With Special Reference to Pulmonary Function Test and Lipid Profile
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Subjective Criteria:
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Patients diagnosed with clinical features of Sthoulya.
- •â€¢ Body mass index should be more than
- •â€¢Subjects signed on informed consent form.
排除标准
- •â€¢Diagnosed with respiratory disorders.
- •â€¢Cardiac diseases •Diabetics and Hypertension.
- •â€¢Abnormal chest wall, Shape, Size •History of renal dysfunction.
结局指标
主要结局
Subjective Criteria:
时间窗: 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.
时间窗: 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).
时间窗: 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)
时间窗: 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)
时间窗: 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),
时间窗: 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),
时间窗: 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
时间窗: 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
时间窗: 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).
时间窗: 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
时间窗: 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.
次要结局
- 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.)