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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2016/05/006903

Enrollment

Registered

2016-05-06

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

Health Condition 1: null- Subclinical Hypothyroidism subjects

Interventions

Intervention1: KSM-66 Ashwagandha (Withania Somnifera): 300 mg twice daily orally with Milk/water in morning and Night for a period of 8 weeks Control Intervention1: placebo: 300 mg twice daily orally

Eligibility

Inclusion criteria

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

Exclusion criteria

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 ( • 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

Design outcomes

Primary

Measure	Time frame
Improvement in T3 T4 & TSH levels from screening to end of therapyTimepoint: after 3 weeks from randomization	—

Secondary

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

Countries

India

Contacts

Public ContactPawan Bhusari

Shre Karthikeya Pharma

drsouvik@ixoreal.com914023204385

Outcome results

None listed

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