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

NCT06826248 | Active Not Recruiting Early Phase 1 DMC

• 1 other identifier: DC-HLWP
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

STUDY OBJECTIVES

1. 1.To assess the safety of Darqeen capsule for the management of Hypothyroidism
2. 2.Evaluate the efficacy of Darqeen capsule for the management of Hypothyroidism
3. 3.To provide an alternative cost-effective treatment for the management of females suffering from hypothyroidism.

Conditions

Hypothyroidism

Keywords

Hypothyroidism; Female Infertility; Hormonal Imbalance; Qillat e Afraz e Darqiyya

Outcome Measures

Primary Outcomes (1)

• Assessment of TSH levels

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

  12 weeks

Study Arms (1)

Single Arm

OTHER

Drug: Darqeen Capsule

Interventions

Darqeen Capsule DRUG

Effect of Darqeen capsule on Thyroid hormones

Single Arm

Eligibility Criteria

• Age: 15 Years - 45 Years
• Gender Eligibility Details: Females
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamdard University: lead

Study Sites (1)

Shifa Ul Mulk Memorial Hospital-Hamdard University

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Hypothyroidism; Infertility, Female

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M Phil Scholar

Model Details: Single Blind, Single Arm

Study Record Dates

• First Submitted: February 1, 2025
• First Posted: February 13, 2025
• Study Start: July 2, 2024
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)