Sttudy to evaluate the efficacy and safety of KSM- 66 Ashwagandha on Subclinical Hypothyroidism patients

Phase 4

Completed

• Conditions: Health Condition 1: null- Subclinical Hypothyroidism subjects

• Registration Number: CTRI/2016/05/006903
• Lead Sponsor: Shri Karthikeya Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-09-07
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

•Male and Female subjects above 18 to 50 years of age and willing to give written inform Consent

•No Significant Medical History

•Ability to understand the risks and benefits of the protocol

•Subject With T3,T4 within Normal Range and TSH to be more than Normal ( 4.5 u IU/L <= 10 u IU/L)

Exclusion Criteria

•Contraindications or hypersensitivity to Ashwagandha and related herbal products

•Subject with Medical History Interfering with the results of the history.

•Subjects already on Nutritional / Energy supplements

•Subject with a history of smoking ( <1 year ago);

•Subject diagnosed with heart disease, diabetes, stroke or other neurological disorders or depression;

•Subject with significant medication use (blood pressure, beta-blockers, inhaled beta agonists, hormonal contraceptives, corticosteroid use within prior three months, psychotropic medication use within prior eight weeks;

•Subject with psychiatric hospitalization within past year

•Subject with body mass index (BMI; kg/m2) > 30

•Currently taking any herbal preparations (such as other formulations containing Ashwagandha, ginseng, Brahmi, Ginkgo biloba)

•Women with a partial or complete hysterectomy, tubal ligations and of menstrual irregularities history

•Women who were pregnant, lactating or with Positive Urine pregnancy test on the day of screening

• History or presence of any medical condition or disease according to the discretion of the Investigator

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in T3 T4 & TSH levels from screening to end of therapyTimepoint: after 3 weeks from randomization

Secondary Outcome Measures

Name	Time	Method
Improvement in morning cortisol level from baseline to end of therapy and clinical safety till the end of studyTimepoint: after 3 weeks from randomization