Health Condition 1: null- Hypothyriod Health Condition 2: E039- Hypothyroidism, unspecified
Conditions
Interventions
Intervention1: Thyro-Q: Thyro-Q one capsule twice a day along with thyroid harmones post meal daily for 120 days.
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Shashik Research Pharma Private Limited
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Thyro-Q in hypothyroid patientsTimepoint: Phase 0- Screening Visit (Day -3 to Day 0) Phase 1- Baseline Visit (Day 0) Phase 2- Treatment period (Day 1 to Day 120) Phase 3- End of Study Visit (Day 120) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
India
Contacts
Public ContactDr D M Ravichand
Shashik Research Pharma Private Limited
Outcome results
None listed