A clinical study to evaluate the safety of cassia tora consumption in humans

A randomized double blind placebo controlled crossover study to assess the nutraceutical properties of Cassia tora in health and well-being

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2014/11/005160

Enrollment

Registered

2014-11-03

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: cassia tora: Cassia tora (dried) leaf powder will be used as intervention agent. 500 mg of the encapsulated cassia tora will be advised for oral consumption thrice in a day for 180 da

Eligibility

Inclusion criteria

Inclusion criteria: • Apparently healthy volunteers in the age range of 20-55 years • Willing to provide written informed consent

Exclusion criteria

Exclusion criteria: • History of a cardiovascular event (myocardial infarction, angioplasty or coronary artery bypass grafting less than a year ago, unstable angina pectoris) • Diabetes mellitus • Uncorrected hypothyroidism • Other metabolic endocrine disease • Uncontrolled hypertension (diastolic blood pressure > 95 mm Hg) • Active liver disease • Severe gastrointestinal disease • Acute inflammatory disease • Severe kidney or other severe disease • Any major surgery within the last year • Use of systemic corticosteroids, anticoagulants, or lipid-lowering drugs • Treatment within the previous 6 months with any medication that is known to affect lipid or lipoprotein levels (such as statins, fibric acid derivatives, bile acid sequestrants, ezetimibe, nicotinic acid, and ACE inhibitors) • Use of anticoagulants and systemic corticosteroids • Pregnant or lactating women

Design outcomes

Primary

Measure	Time frame
Safety of Cassia tora will be assessed by recording adverse events that occur during the course of the study. In addition, blood testing will be before, during and after treatment phase for complete blood count , sodium, potassium, chloride, blood urea nitrogen, creatinine, uric acid, alanine transaminase, gamma-glutamyl transferase, total bilirubin.Timepoint: Data will be captured upon recruitment and every three months interval ( 6 months drug and 6 months placebo with a washout period of one month in between placebo and drug).	—

Measure

Time frame

Safety of Cassia tora will be assessed by recording adverse events that occur during the course of the study. In addition, blood testing will be before, during and after treatment phase for complete blood count , sodium, potassium, chloride, blood urea nitrogen, creatinine, uric acid, alanine transaminase, gamma-glutamyl transferase, total bilirubin.Timepoint: Data will be captured upon recruitment and every three months interval ( 6 months drug and 6 months placebo with a washout period of one month in between placebo and drug).

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Secondary

Measure	Time frame
To determine the effects of daily dosing of Cassia tora for 6 months on blood lipid profiles (Total-cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, Lipoprotein (a), apo-B, apo-A1).Timepoint: Secondary outcome measures will be done in day of recruitment and every three months interval ( 6 months drug supplementation and 6 months placebo with a washout period of one month in between drug and placebo).;To determine the effects of Cassia tora on blood pressure (BP), body weight, and body-mass index and well being.Timepoint: Secondary outcome measures will be done in day of recruitment and every three months interval ( 6 months drug supplementation and 6 months placebo with a washout period of one month in between drug and placebo).;To determine the effects of Cassia tora on fasting levels of blood glucose, hemoglobin A1c and insulin.Timepoint: Secondary outcome measures will be done in day of recruitment and every three months interval ( 6 months drug supplementation and 6 months placebo with a washout period of one month in between drug and placebo).;To determine the effects of Cassia tora on lipid peroxidation and antioxidant enzymes and vitamins.Timepoint: Secondary outcome measures will be done in day of recruitment and every three months interval ( 6 months drug supplementation and 6 months placebo with a washout period of one month in between drug and placebo).	—

Measure

Time frame

To determine the effects of daily dosing of Cassia tora for 6 months on blood lipid profiles (Total-cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, Lipoprotein (a), apo-B, apo-A1).Timepoint: Secondary outcome measures will be done in day of recruitment and every three months interval ( 6 months drug supplementation and 6 months placebo with a washout period of one month in between drug and placebo).;To determine the effects of Cassia tora on blood pressure (BP), body weight, and body-mass index and well being.Timepoint: Secondary outcome measures will be done in day of recruitment and every three months interval ( 6 months drug supplementation and 6 months placebo with a washout period of one month in between drug and placebo).;To determine the effects of Cassia tora on fasting levels of blood glucose, hemoglobin A1c and insulin.Timepoint: Secondary outcome measures will be done in day of recruitment and every three months interval ( 6 months drug supplementation and 6 months placebo with a washout period of one month in between drug and placebo).;To determine the effects of Cassia tora on lipid peroxidation and antioxidant enzymes and vitamins.Timepoint: Secondary outcome measures will be done in day of recruitment and every three months interval ( 6 months drug supplementation and 6 months placebo with a washout period of one month in between drug and placebo).

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Countries

India

Contacts

Public ContactDr T Muneeswara Reddy MD

Sri Venkateswara University

kanalakr@yahoo.com919490491276

Outcome results