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

NCT ID: NCT06826248

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-02
• Study Completion Date: 2025-12-31

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.

Conditions

Hypothyroidism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm

Group Type: OTHER

Darqeen Capsule

Intervention Type: DRUG

Effect of Darqeen capsule on Thyroid hormones

Interventions

Darqeen Capsule

Effect of Darqeen capsule on Thyroid hormones

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hamdard University

OTHER

Sponsor Role: lead

Responsible Party

Khadija Shaikh

M Phil Scholar

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shifa Ul Mulk Memorial Hospital-Hamdard University

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

DC-HLWP

Identifier Type: -

Identifier Source: org_study_id