Efficacy and Safety of Thyro-Q in Hypothyroid patients on Thyroid Hormone Therapy

Phase 3

Completed

• Conditions: Health Condition 1: null- HypothyriodHealth Condition 2: E039- Hypothyroidism, unspecified

• Registration Number: CTRI/2018/05/013618
• Lead Sponsor: Shashik Research Pharma Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-10-12
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1. Male/ Females subjects between 18-60 years

of age

2. Subjects able to communicate effectively.

3. Subjects willing to provide written informed

consent

4. In the judgment of the Principal

Investigator, able to comply with protocol

requirements.

5. Ability to schedule and attend monthly

visits for the duration of the study.

6. Primary hypothyroidism >=6 months

7. Thyroxine dose >=50 mcg/day

8. No change in thyroxine dose in past 2 months

9. Serum TSH of 0.1-4.8 mU/L

10.Adequate contraceptive measures for women

of childbearing age

Exclusion Criteria

1. Contraindications or Hypersensitivity to

study product.

2. History or presence of any medical condition

or disease according to the discretion of

the Investigator.

3. No contraindications to exercise as outlined

by the American Endocine society (ACS).

4. Subjects who are under herbal supplements

within seven (7) days prior to screening.

5. Subjects having history of asthma.

6. Subjects having history of cardiovascular

diseases.

7. Subjects having history of diabetes (Type I

or Type II) except other than the subject

having the pre-diabetes condition with the

fasting blood glucose between 100 to 125

mg/dl or random blood glucose > 140-199

mg/dl.

8. Subjects having BP above 180/100 or below

80/50 mmHg

9. Subjects having hyperthyroid disease.

Subjects having abnormal findings on

complete blood count

10.Subjects with HIV Positive.

11.Subjects having history of high alcohol

intake (2 standard drinks per day).

12.Subjects having history of psychiatric

disorder that may impair the ability of

subjects to provide written informed

consent.

13.Any other condition that, in the opinion of

the investigator, would adversely affect the

subjectâ??s ability to complete the study or

its measures.

14.Subjects participated in any clinical study

within thirty (30) days prior to screening.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of Thyro-Q in hypothyroid patientsTimepoint: Phase 0- Screening Visit (Day -3 to Day 0) <br/ ><br>Phase 1- Baseline Visit (Day 0) <br/ ><br>Phase 2- Treatment period (Day 1 to Day 120) <br/ ><br>Phase 3- End of Study Visit (Day 120) <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of Thyro-Q in hypothyroid patients on thyroid harmone therapyTimepoint: Day 0, Day 30, Day 60, Day 90 and Day 120.