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Tab Thyrosutra as add-on treatment for managing Hypothyroidism.

Effect of Tab Thyrosutra as an add-on treatment for management of hypothyroidism: A randomized clinical trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/074028
Enrollment
60
Registered
2024-09-19
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

None listed

Sponsors

Dr Smita Naram
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Pre diagnosed hypothyroidism (Diagnosis on the basis of Sr. TSH, T3 and T4 levels) individuals of either sex of age group between 18 - 60 years receiving a stable dose of levothyroxin for past 6 months willing to participate in trial with informed written consent. 2. With controlled co-morbidity (viz. Diabetes Mellitus, Hypertension, BMI

Exclusion criteria

Exclusion criteria: 1. Juvenile groups pregnancy and breast feeding women 2. Systemic diseases like hypertension like malignant hypertension, BP systolic greater than or equal to 100 mm/hg and diastolic greater than or equal to 160 mm/hg, diabetes fasting BSL greater than or equal to 200g/dl and postprandial BSL greater than or equal to 350g/dl, known cases of cardiac complications (angina, Myocardial infarction, CAD, post PTCA etc), known cases of pulmonary diseases (pulmonary tuberculosis, ARDS etc), known cases of hepatic complication (Liver cirrhosis, alcoholic liver diseases, jaundice etc) known cases of renal complications (Chronic kidney disease, hydronephrosis), known cases of cancer patients of ongoing chemo-radiation therapy, known cases status epileptics 3. Patients dependent on steroid (who is taking uninterrupted steroid for more than one year in the dose of 0.3 mg/kg/day or higher doses in short span) addictions of narcotic substances 4. Patients with inability to comprehend and complete study assessments as per instructions. 5. Patients with inability to attend or complete the proposed course of intervention and follow-up schedule

Design outcomes

Primary

MeasureTime frame
Normalcy of T3, T4 and TSH with reduction in levothyroxine dose, improvement in quality of life and hypothyroid associated symptomsTimepoint: At 12 weeks: Normalcy of T3, T4 and TSH with reduction in levothyroxine dose At 6-12 weeks: improvement in quality of life At 4 weeks: Improvement in hypothyroid associated symptoms

Secondary

MeasureTime frame
Improvement in associated symptoms like loss of appetite, weight gain, weakness, constipation, muscle stiffness, puffiness, sleep disturbanceTimepoint: Loss of appetite: 2 to 3 weeks weight loss: 3 to 4 kg after 3 months Decrease weakness: after 3 months decrease Constipation: 1 week reduce Muscle stiffness: after one month reduce puffiness: after 2 months reduce Sleep disturbances: after 3 months

Countries

India

Contacts

Public ContactDr Komal Gawali

Dr D Y Patil College of Ayurved and Research Center Pimpri Pune

drswagata32@gmail.com7984956017

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026