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Clinical Trials/CTRI/2011/091/000222
CTRI/2011/091/000222
Completed
Phase 1

A Single Centre, Prospective, Randomized, Double-blind Placebo Controlled Study of Safety And Efficacy of KSM-66 in Healthy Adults.

Ixoreal Biomed Priavte Limited,#5-9-225, 3rd floor, Sanali estate, Chirag ali lane, Abids,Hyderabad, Andhra Pradesh- 500001, India0 sites60 target enrollmentTBD
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Ixoreal Biomed Priavte Limited,#5-9-225, 3rd floor, Sanali estate, Chirag ali lane, Abids,Hyderabad, Andhra Pradesh- 500001, India
Enrollment
60
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

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

Investigators

Sponsor
Ixoreal Biomed Priavte Limited,#5-9-225, 3rd floor, Sanali estate, Chirag ali lane, Abids,Hyderabad, Andhra Pradesh- 500001, India

Eligibility Criteria

Inclusion Criteria

  • •?Healthy adults of either sex, who are facing routine work stresses, who sign the Informed Consent Form.
  • •?Age group 18 \-54 years
  • •?Can read , write and understand English
  • •?Subjects with WHO\-5 well being index \< 15 or PSS scores \>14

Exclusion Criteria

  • •?Suffering from any chronic physical, hormonal or psychiatric illness
  • •?Current substance dependence
  • •?Individuals refusing to use appropriate non\-hormonal birth control measures.
  • •?Pregnancy / lactating mothers
  • •?Currently taking any other medication on a regular basis
  • •?Currently taking any herbal preparations (other formulations containing ashwagandha / ginseng / ginkgo biloba / brahmi etc)
  • •?Clinically significant findings on laboratory investigations and ECG

Outcomes

Primary Outcomes

Not specified

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