A Clinical trial of CV-HFT01 tablets as Adjuvant Therapy in patients with hypothyroidism

An Open Label Clinical trial to assess the Safety and Efficacy of CV-HFT01 tablets as Adjuvant Therapy in patients with hypothyroidism - CV-HFT01

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/04/018564

Enrollment

Registered

2019-04-11

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: E039- Hypothyroidism, unspecified

Interventions

Intervention1: CV-HFT01 tablets: 1 tablet of CV-HFT01 twice daily orally before meal with water for 3 months along with the ongoing treatment for hypothyroidism. Subjects will be advised lifestyle mod

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and Female subjects of age 18 to 50 years (both inclusive) and willing to give written inform Consent 2. No Significant Medical History 3. Ability to understand the risks and benefits of the protocol 4. Subject With T3, T4 within Normal Range and TSH to be more than normal ( >4.5 u IU/L

Exclusion criteria

Exclusion criteria: 1.Women with a partial or complete hysterectomy, tubal ligations history 2.Women who are pregnant or lactating 3.Smokers/Alcoholics and/or drug abusers 4.Patient with poorly controlled Hypertension 5.Patients with evidence of malignancy 6.Patients receiving any herbal, Ayurvedic, homeopathic, siddha or unani medicine for hypothyroidism 7.History or presence of any medical condition or disease according to the discretion of the Investigator

Design outcomes

Primary

Measure	Time frame
To assess improvement in T3 T4 & TSH levels from screening to end of treatmentTimepoint: Screening Visit , Visit 1 (Day 30) Visit 2 (Day 60) Visit 3 (Day 90)	—

Secondary

Measure	Time frame
1.Improvement in subjective assessment of clinical symptoms like changes in body weight, anxiety, fatigue and excessive sweating related to hypothyroidism. 2.To evaluate tolerability and safety of CV-HFT01 tablets in patients with hypothyroidism Timepoint: Screening Visit , Baseline Visit Visit 1 (Day 30) Visit 2 (Day 60) Visit 3 (Day 90)	—

Countries

India

Contacts

Public ContactMr Prateek Shastrakar

Climic Health Pvt Ltd

veenadeo@hotmail.com9371490527

Outcome results

None listed

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