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A clinical research trial to find the safety and effectiveness of asgand and brahmi in underactive thyroid gland function

A Randomized,Active-Controlled,Assessor-Blinded,Parallel Group Clinical Study to evaluate the safety and efficacy of Asgand and Brahmi in the Management of Qillat-e-Darqiyyat Asli (Primary Hypothyroidism) - PGJV

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/04/024655
Enrollment
45
Registered
2020-04-15
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: Asgand and Brahmi: Asgand and Brahmi 6 gms powder twice daily orally with water after meals. Control Intervention1: Levothyroxine: 50 mcg 2 tablets once daily orally with water before m

Sponsors

National Research Institute of Unani Medicine for Skin Disorders Hyderabad
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of any gender Patients in the age group between 19 and 60 years Patients with Symptomatic Subclinical Primary Hypothyroidism Patients with Clinical Primary Hypothyroidism TSH ranging 5-10mg/dl

Exclusion criteria

Exclusion criteria: Patients aged 60 years Asymptomatic cases of Subclinical Primary Hypothyroidism Severe/ complicated cases of Clinical Primary Hypothyroidism Patients with Drug-induced Hypothyroidism Patients on radiotherapy for head and neck region ï?· Patients who have undergone thyroidectomy ï?· Pregnant or Lactating Women ï?· Significant Pulmonary/ Cardiovascular/ Hepatic/ Renal Diseases ï?· Known cases of Immunocompromised states (HIV/ AIDS, etc.)/ Malignancies ï?· Patients with Diabetes Mellitus ï?· Patients with history of hypersensitivity to Asgand or Brahmi ï?· Patient not willing to attend treatment schedule regularly

Design outcomes

Primary

MeasureTime frame
Clinical assessment will be done at 0, 2, 4 ,6 and 8 weeks and the response to treatment will be assessed using the following parameters: 1. Decrease in serum TSH level 2. Increase in serum Free T4 level 3. Improvement in the symptoms & signs of hypothyroidism as assessed by reduction in Zulewskiâ??s clinical score after treatmentTimepoint: 2nd week 4th week 6th week 8th week

Secondary

MeasureTime frame
Lab investigationTimepoint: 0 and 8 weeks

Countries

India

Contacts

Public Contactjuveria jabeen

National Research Institute of Unani Medicine for Skin Disorders

ccrumhqrsnd58@gmail.com8700027178

Outcome results

None listed

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