Clinical Efficacy of Darqeen Capsule for the Management of Hypothyroidism Associated with Female Reproductive Hormonal Imbalance

Early Phase 1

Active, not recruiting

• Conditions: Hypothyroidism
• Interventions: Drug: Darqeen Capsule

• Registration Number: NCT06826248
• Lead Sponsor: Hamdard University

Brief Summary

STUDY OBJECTIVES

1. To assess the safety of Darqeen capsule for the management of Hypothyroidism

2. Evaluate the efficacy of Darqeen capsule for the management of Hypothyroidism

3. To provide an alternative cost-effective treatment for the management of females suffering from hypothyroidism.

NULL HYPOTHESIS (HO) The Unani Medicine Darqeen capsule is not effective for the management of Hypothyroidism.

ALTERNATE HYPOTHESIS (H1) Unani medicine Darqeen capsule is effective for the management of Hypothyroidism.

Detailed Description

Hypothyroidism is a common endocrine disorder characterized by deficiency in the thyroid hormones, thyroxine (T4) and triiodothyronine (T3) which are crucial for regulating metabolism and maintaining overall bodily functions. There are several etiologies and manifestations of hypothyroidism. The most common clinical signs are weight gain, hair loss, sensitivity to cold, tiredness, constipation, dry skin, and voice changes.

The prevalence in Pakistan has been a growing concern, necessitating extensive research to address the underlying causes, risk factors, and optimal management strategies. It is estimated that hypothyroidism impacts approximately 5% of the population and 15% in females, with up to 5% possibly having undiagnosed thyroid failure. In Pakistan, the prevalence of hypothyroidism is reported to be 4.1%.

The description of Qillat-e-Ifraz-e-Darqiyya (hypothyroidism) in Unani system of medicine resembles the clinical manifestation associated with Su-e-Mizaj Barid Maddi (derangement in cold temperament).

The management of hypothyroidism involves thyroid hormone replacement therapy with levothyroxine, regular monitoring of hormone levels, and lifestyle modifications like a balanced diet, exercise, and stress management. Iodine supplementation is recommended in iodine-deficient regions, while underlying causes and pregnancy considerations should be managed. Educating patients about their condition and treatment plan is essential for active involvement in their health management.

Darqeen capsule is an Unani polyherbal formulation that primarily consists of natural ingredients, it is time tested pharmacopoeia formulation that is further modified by Hamdard Research Center. It is being used clinically for more than two years at Hamdard Matabs all around Pakistan and found effective for managing hypothyroidism and its associated symptoms.

Study Timeline

• Study Start: 2024-07-02
• Status Verified: 2025-01
• Study First Submitted: 2025-02-01
• Study First Submitted QC: 2025-02-12
• Last Update Submitted: 2025-02-12
• Study First Posted: 2025-02-13
• Last Update Posted: 2025-02-13
• Primary Completion: 2025-10-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• Subjects diagnosed with hypothyroidism
• Having raised TSH
• T3 & T4 hormones level below normal limits
• Females between the age group of 15-45 years

Exclusion Criteria

• Subjects below the age group of 15 and above 45
• Suffering from chronic liver diseases and kidney failure, cancer or any other comorbid condition
• Currently taking any medication for Hypothyroidism or having history of adverse drug reaction
• Pregnant and lactating mothers.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Darqeen Capsule	-

Primary Outcome Measures

Name	Time	Method
Assessment of TSH levels	12 weeks	Thyroid Stimulating Hormone-TSH level evaluated at baseline and compare with post treatment levels (after 12 weeks of treatment).

Trial Locations

Locations (1)

Shifa Ul Mulk Memorial Hospital-Hamdard University; 🇵🇰 Karachi, Sindh, Pakistan