A study to test the safety and effectiveness of Qust Shirin (a Unani medicine) in people with hypothyroidism (underactive thyroid)

A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to evaluate the Safety and Efficacy of Qust Shirin (Saussurea lappa) compared with Levothyroxine in the Management of Qillat-i-Darqiyyat Asli (Primary Hypothyroidism) - Nil

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/10/096363

Enrollment

Registered

2025-10-22

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

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: Qust Shirin (Saussurea Lappa): Qust Shirin (Saussurea lappa) 1g (powder) Twice daily Orally in the form of capsule. 2 capsules (500mg each) twice daily Orally With water after meals for

Eligibility

Inclusion criteria

Inclusion criteria: Participants who meet the following criteria will be included in the study: 1. Individuals of any gender 2. Aged between 18 and 60 years 3. Participants diagnosed with symptomatic subclinical primary Hypothyroidism with elevated TSH(10-20mIU/L) and normal Free T4/T3) 4. Participants diagnosed with overt primary Hypothyroidism with elevated TSH (10-20mIU/L) and low free T4

Exclusion criteria

Exclusion criteria: The following participants will be excluded from the study: 1. Individuals aged Below 18 years or Above 60 years 2. TSH Level Less than 10mIU/L or More than 20mIU/L 3. Asymptomatic cases of Subclinical Primary Hypothyroidism 4. Severe or complicated cases of Overt Primary Hypothyroidism 5. Patients with Drug-induced Hypothyroidism 6. Patients undergoing radiotherapy to the head or neck region 7. Individuals who have undergone thyroidectomy 8. Pregnant or Lactating Women 9. Patients with significant pulmonary, cardiovascular, hepatic, or renal diseases 10. Known cases of immunocompromised states (e.g., HIV/AIDS) or malignancies 11. Patients with Diabetes Mellitus 12. Individuals with a history of hypersensitivity to Qust Shirin 13. Patients unwilling or unable to comply with the treatment schedule

Design outcomes

Primary

Measure	Time frame
Primary Outcome Measures 1.Change in Serum Thyroid Stimulating Hormone (TSH) Levels from baseline to 8 weeks of Treatment 2. Change in Serum Free Thyroxine (FT4) Levels from baseline to 8 weeks of TreatmentTimepoint: At Baseline and 8 week	—

Secondary

Measure	Time frame
Monitoring Adverse Events (AEs) Adverse effects related to either the Unani drug or control drug will be documented at each clinical assessment visit (weeks 2,4,6 and 8), both as reported by the participants,and observed by the physician during clinical examination. Timepoint: 2,4,6 and 8 weeks;1. Changes in Laboratory Parameters from baseline and at week 8 2. Change in Serum Free Triiodothyronine (FT3) Levels from baseline to week 8 3. Change in Zulewski’s Clinical Score from baseline to week 8 4. Change in Lipid Profile Parameter from baseline to 8 weeks of treatment 5. Change in Participants’ Quality of Life (QoL),assessed using the Thyroid-Dependent Quality of Life Questionnaire (ThyDQoL),from baseline to week 8Timepoint: At Baseline and week 8	—

Measure

Time frame

Monitoring Adverse Events (AEs) Adverse effects related to either the Unani drug or control drug will be documented at each clinical assessment visit (weeks 2,4,6 and 8), both as reported by the participants,and observed by the physician during clinical examination. Timepoint: 2,4,6 and 8 weeks;1. Changes in Laboratory Parameters from baseline and at week 8 2. Change in Serum Free Triiodothyronine (FT3) Levels from baseline to week 8 3. Change in Zulewski’s Clinical Score from baseline to week 8 4. Change in Lipid Profile Parameter from baseline to 8 weeks of treatment 5. Change in Participants’ Quality of Life (QoL),assessed using the Thyroid-Dependent Quality of Life Questionnaire (ThyDQoL),from baseline to week 8Timepoint: At Baseline and week 8

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Countries

India

Contacts

Public ContactProf Qamar Uddin

National Research Institute of Unani Medicine for Skin Disorders Hyderabad

qamaruddindr@gmail.com8700027178

Outcome results

None listed

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