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临床试验/NCT06826248
NCT06826248进行中(未招募)1 期

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

Hamdard University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年7月2日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
50
试验地点
1
主要终点
Assessment of TSH levels

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
15 Years 至 45 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

Single Arm

Other

干预措施: Darqeen Capsule (Drug)

结局指标

主要结局

Assessment of TSH levels

时间窗: 12 weeks

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Khadija Shaikh

M Phil Scholar

Hamdard University

研究点 (1)

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