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To assess effect of oral herbal capsule to improve HDL, DHEA and insulin level.

A single centre, open label study to assess the safety and efficacy of oral herbal capsule to improve HDL, DHEA and insulin level in healthy volunteers. - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2015/10/006277
Enrollment
50
Registered
2015-10-19
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: Herbal Capsule: 500mg capsule containing herbal extract for oral application, 3 times a day for 30 days Control Intervention1: Nil: Nil

Sponsors

Spectrum Clinical Research Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Healthy volunteers of age 20 to 55 years of either sex who are not involved in any regular medication or supplementation. 2.Subjects having HDL level normal, lower and less than lower range at screening visit. 3.Subjects who are willing to give their written informed consent and comply with the protocol requirements.

Exclusion criteria

Exclusion criteria: 1.Pregnant or lactating women. 2.Subjects with known hypersensitivity to the investigational products. 3.Subjects who have participated in any clinical trial in the past 1 month. 4.Any subjects found to have entered in to the study in violation of this protocol or if the subject is uncooperative during the study. 5.Any other condition that in the opinion of the investigator that does not justify the subjectâ??s participation in the trial

Design outcomes

Primary

MeasureTime frame
To evaluate the effect of treatment on HDL, DHEA and insulin levelTimepoint: 15 and 30 Days from Baseline Visit

Secondary

MeasureTime frame
To evaluate the effect of treatment on following parameters such as TC, VLDL, LDL, TG, TC/HDL ratio, LDL/HDL ratio, Testosterone, Thrombotic (PT and PTT), renal profile, Homocysteine, Estradiol and AMHTimepoint: 30 Days from Baseline Visit

Countries

India

Contacts

Public ContactSanjay Vekariya

Spectrum Healthcare

sghosh@spectrumhealthcare.co.in02225777755

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026