A Clinical trial of CV-HFT01 tablets as Adjuvant Therapy in patients with hypothyroidism
- Conditions
- Health Condition 1: E039- Hypothyroidism, unspecified
- Registration Number
- CTRI/2019/04/018564
- Lead Sponsor
- Climic Health Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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 < 10 u IU/L) and with or without receiving on-going conventional medication for the same.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1.Improvement in subjective assessment of clinical symptoms like changes in body weight, anxiety, fatigue and excessive sweating related to hypothyroidism. <br/ ><br>2.To evaluate tolerability and safety of CV-HFT01 tablets in patients with hypothyroidism <br/ ><br>Timepoint: Screening Visit , Baseline Visit Visit 1 (Day 30) Visit 2 (Day 60) Visit 3 (Day 90)