A Study to see the efficacy of Asgandh (Withania Somnifera) in Primary Hypothyroidism

Phase 3

Not yet recruiting

Conditions: Hypothyroidism, unspecified,

Registration Number: CTRI/2020/03/023913

Lead Sponsor: Luqman Unani Medical College Hospital and Research Centre

Brief Summary: Enrolled cases of primary hypothyroidism after obtaining a written informed consent will be randomly allocated into 2 groups, viz; Group A and Group B, 20 subjects in each group. The Group-A subjects will be given Asgandh in dose of 1gm twice a day in empty stomach with normal water plus Levothyroxine sodium with dosage of 50mcg once a day in empty stomach with normal water. Group-B subjects will be given Levothyroxine sodium 50mcg once a day in empty stomach with normal water for 60 days. All the patients will be assessed for subjective symptoms fortnightly and Thyroid profile Level before and after the treatment. The data for both the groups will be statistically analysed and compared with each other using appropriate statistical tests. The significance difference of p <0.05 will be taken into consideration for efficacy outcome.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

1 Clinically diagnosed and know cases of primary hypothyroidism with or without treatment.
2 Patients having TSH level range between 10-20 mu/I.
3 Patients who are willing to give consent.

Exclusion Criteria

1 Subjects with clinically significant renal, hepatic, endocrine (including diabetes mellitus), cardiac, pulmonary, pancreatic, neurologic, hematologic disorder 2 Hyperthyroidism 3 Pregnant and lactating mothers 4 Patients who fail to give consent.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in objective parameters	60 Days

Secondary Outcome Measures

Name	Time	Method
Fatigue	Cold intolerance

Trial Locations

Locations (1): Luqman Unani Medical College, Hospital & Research Centre
🇮🇳
Bijapur, KARNATAKA, India
Luqman Unani Medical College, Hospital & Research Centre
🇮🇳Bijapur, KARNATAKA, India
Md Majid Hussain
Principal investigator
8282929092
drmajid8282@gmail.com