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Clinical Trials/CTRI/2023/04/051632
CTRI/2023/04/051632
Not yet recruiting
未知

A clinical study to evaluate safety of standardized Ashwagandha (Withania somnifera) extract capsules in healthy male volunteers - Nil

Pharmanza Herbal Pvt. Ltd.0 sites0 target enrollmentTBD
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Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Pharmanza Herbal Pvt. Ltd.
Status
Not yet recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Male subjects having age between 18 to 60 years (both inclusive) 2\. BMI between 18\.5 and 24\.9 kg/m2 (both inclusive) 3\. Apparently mentally and physically healthy and biochemical parameters within normal reference ranges 4\. Willingness to complete the study interventions and follow\-up 5\. Subjects with normal cardiovascular function with no evidence of acute ischemic heart disease in the electrocardiogram 6\. The subject willing to provide consent and visit on follow up and abide protocol related requirements.

Exclusion Criteria

  • •1\. Being on a medically prescribed drug or supplements
  • •2\. Reported weight loss/gain \>10% of body weight in the 6\-month preceding pre\-study examination
  • •3\. Using herbal supplements or dietary supplements meant for improving health and wellbeing
  • •4\. History of hypersensitivity to Ashwagandha
  • •5\. Undergoing medical treatment that may interfere with the study outcome
  • •6\. Consuming alcohol, smoking and/ or chewing tobacco during the past 6 months
  • •7\. Recreational drug use during the past 6 months
  • •8\. Subjects with diagnosis of an active disease and/or receiving pharmacological treatment prescribed for an active disease and who have evidence of an active disease at the time of the initial clinical examination at the discretion of the investigator
  • •9\. Any other major clinical disease or psychiatric disorder that, at the discretion of the investigator, precludes the administration or completion of the protocol treatment.

Outcomes

Primary Outcomes

Not specified

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