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

Phase 1

Completed

• Conditions: Healthy Human Volunteers

• Registration Number: CTRI/2012/06/002713
• Lead Sponsor: Alkem Laboratories Ltd

Brief Summary

After Ethics committee’s clearance for the clinical study, healthy individuals will be screened at Department of Kayachikitsa, Sumatibhai Shah Ayurved Mahavidyalaya and Hospital, Hadapsar, Pune. Those meeting inclusion criteria and ready to provide written informed consent will be recruited in the study. The treatment will be given on OPD basis. Considering 20% dropout rate, 36 healthy individuals will be recruited in the study to get 30 evaluable cases at the end of the study.

On screening visit, a written informed consent will be obtained from subjects for their participation in the study. Subject will be inquired about presence of any disease and medication for the same. If subject is suffering from any disease, he/she will not be included in the study. Subject’s general (vital signs and symptoms) and systemic examinations will be done. Then subject will undergo laboratory investigations viz. CBC, ESR, Hb%, Blood Sugar Fasting, HIV, HbsAg, Liver profile, lipid profile, renal profile, Urine routine and microscopic and Urine pregnancy test (for females of fertile age). Subjects will also undergo X-ray chest PA view and ECG examinations.

A wash out period of 3 days will be given. During washout period and the whole study period (viz. 28 days + 7 days), subject will be advised to refrain from any medication (Ayurvedic, allopathic, homeopathic etc.) other than study medication i.e. Jeevanprash.

On baseline visit (Day 0), subjects will be recruited in the study if he/she meets all the inclusion criteria. Subject will be inquired about occurrence of adverse event. Subjects will then undergo general (including vital signs and symptoms) and systemic examinations. After the baseline visit, subjects will be called at OPD of Sane Guruji Aarogya Kendra hospital on 7th day, 14th day, 21st day, 28th day and 35th day of the treatment.

At baseline visit all subjects included in the trial will be provided with a Jar of Jeevanprash weighing 500 gm (280 grams for 28 days + 30 grams in case, if follow up is delayed maximum upto 3 days). All the subjects will be advised to consume 10 gm of Jeevanprash in the morning on empty stomach with lukewarm water daily for 28 days. After 28 days, the subjects will be asked to stop taking Jeevanprash and they will be observed for next 7 days for any adverse event. All subjects will be asked to give back the balance quantity of Jeevanprash on 28th day.

On every follow up visit, subjects will undergo general and systemic examination. Tolerability of the trial medicine will be assessed by the investigator and by the subject on day 28 and at the end of the study i.e. on day 35. Drug compliance will also be assessed by the investigator on every visit starting from first follow up visit till day 28. All the subjects will be closely monitored for any adverse events/ adverse drug reactions on every visit till the completion of the study.

On day 28, subjects will be advised to undergo laboratory investigations viz. CBC, ESR, Hb%, Blood Sugar Fasting, Liver profile, Lipid profile, Renal profile and Urine routine and microscopic. On last visit i.e. on day 35, all the subjects will be informed that the study visits are over and their further course of treatment will be decided by the investigator.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-23
• Last Update Posted: 2014-02-28

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

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

• Subjects meeting any of the following criteria will be excluded from the trial- • Any significant disease condition which would affect subject’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 (<2 years) or consumption of alcohol within 48 hours of receiving study medication.
• • 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the clinical safety of JP in healthy individuals in summer by assessing Vital signs & symptoms, General and systemic examinations	Baseline to 35 days

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Kayachikitsa; 🇮🇳 Pune, MAHARASHTRA, India

Department of Kayachikitsa

🇮🇳Pune, MAHARASHTRA, India

Dr Vaishali Shailesh Deshpande

Principal investigator

9096082950

dr.vaishalid@gmail.com