A clinical study to evaluate the Safety of Jeevanprash (JP) in Healthy Individuals in Summer.

An Open Labeled, Prospective, Single-center, Clinical Study to Evaluate the Safety of Jeevanprash (JP) in Healthy Individuals in Summer. - NIL

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2012/06/002713

Enrollment

Registered

2012-06-04

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: Jeevanprash Awaleha: Each 100 gm of Jeevanprash Awaleha contains: Sr. No. Ingredients Quantity 1 Amla 80g 2 Dashmool 4 g 3 Vanshlochan 0.5 gms 4 Bala, Mudagparni, Mashaparni, Karkatshi

Eligibility

Inclusion criteria

Inclusion criteria: Subjects meeting all of the following criteria will be included to the trial- • Males and Females, age group between 20-40 years • Ready to provide written informed consent • No significant diseases or clinically abnormal laboratory blood profiles during screening. • ECG without significant abnormalities • Be able to communicate effectively with study personnel • No history of allergic conditions and is not on regular medical treatment

Exclusion criteria

Exclusion criteria: Subjects meeting any of the following criteria will be excluded from the trial- • Any significant disease condition which would affect subjectâ??s participation or compliance to study protocol • History of allergic conditions • History of autoimmune disorders • History of HIV I & II, Hepatitis. • History or presence of dyspepsia, gastric ulcer or duodenal ulcer. • History of any psychiatric disorders. • Intake of any medication within 14 days before the start of the study. • Recent history of alcoholism ( • Smokers who cannot refrain from smoking during the study period. • Presence of clinically significant abnormal laboratory results during screening. • Pregnancy or not using appropriate means of contraception. • History of drug addiction.

Design outcomes

Primary

Measure	Time frame
To assess the clinical safety of JP in healthy individuals in summer by assessing Vital signs & symptoms, General and systemic examinationsTimepoint: Baseline to 35 days	—

Secondary

Measure	Time frame
To assess the safety of JP in healthy individuals in summer by assessing 1). Tolerability of the study drug by the subject at the end of 28 days of study treatment. 2). Tolerability of the study drug by the investigator at the end of 28 days of study treatment. 3). Incidence, severity and duration of adverse event(s). 4). Laboratory investigations. Timepoint: Baseline to 35 days	—

Countries

India

Contacts

Public ContactDr Sanjay Tamoli

Target Institute of Medical Education & Research

sanjaytamoli@hotmail.com09322522252

Outcome results