A randomized Double Blinded placebo controlled comparative study to evaluate the effect of KSM-66Ashwagandha (Withania Somnifera) on Subclinical Hypothyroidism patient and their Cortisol Level

Shri Karthikeya Pharma0 个研究点目标入组 50 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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)

•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

发起方

Shri Karthikeya Pharma