Effect of a herbal medicine in hypothyroidism

A Randomized Non-inferiority Trial on the efficacy of polyherbal formulation in the management of the Clinical symptoms and Quality of life in Hypothyroidism

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/03/032428

Enrollment

104

Registered

2021-03-30

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 Health Condition 2: E039- Hypothyroidism, unspecified

Interventions

Intervention1: A Polyherbal medicine made of Aswagandha Brahmi Makandi Guggulu Punarnava Madhuka Vasaka Pippali Guduchi Salaparni Nimba: Plan of study: After fulfilling the criteria for selection, a

Eligibility

Inclusion criteria

Inclusion criteria: Known cases and newly determined cases of Hypothyroidism. In between the age group of 18-60 years. Serum TSH level more than 4.5 to 20 IU/ mL

Exclusion criteria

Exclusion criteria: Female patients who are pregnant. Known cases of any congenital anomaly. BMI more than 30 Patients with post thyroidectomy status, ischemic heart disease, uncontrolled hypertension, myocardial infarction, cerebrovascular event, cardiac arrhythmias and active malignant diseases

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy of a polyherbal formulation in the management of clinical symptoms in Hypothyroidism. To compare the efficacy of the polyherbal formulation against Thyroxine supplementation in managing the clinical symptoms of Hypothyroidism. Timepoint: 0 day - Clinical parameters, TSH value, Thyropro39 score 60th day - Clinical parameters, TSH value, Thyropro39 score 90th day - Clinical parameters and Thyropro 39 score	—

Measure

Time frame

To evaluate the efficacy of a polyherbal formulation in the management of clinical symptoms in Hypothyroidism. To compare the efficacy of the polyherbal formulation against Thyroxine supplementation in managing the clinical symptoms of Hypothyroidism. Timepoint: 0 day - Clinical parameters, TSH value, Thyropro39 score 60th day - Clinical parameters, TSH value, Thyropro39 score 90th day - Clinical parameters and Thyropro 39 score

—

Secondary

Measure	Time frame
To evaluate the safety of the polyherbal formulation in participants of the clinical trial during the period of study. To evaluate the efficacy of the polyherbal formulation in improving the Quality of life in participants with hypothyroidism. Timepoint: 0 day - LFT and RFT evaluation 60th day - LFT and RFT evaluation 90th day	—

Countries

India

Contacts

Public ContactAnand P K V

Parul Institute of Ayurveda

dr.vaishalid@gmail.com9096082950

Outcome results

None listed

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