Clinical Efficacy of Darqeen Capsule for the Management of Hypothyroidism Associated with Female Reproductive Hormonal Imbalance
STUDY OBJECTIVES
- To assess the safety of Darqeen capsule for the management of Hypothyroidism
- Evaluate the efficacy of Darqeen capsule for the management of Hypothyroidism
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
Sindh
-
Karachi, Sindh, Pakistan
- Shifa Ul Mulk Memorial Hospital-Hamdard University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Single Arm
|
Effect of Darqeen capsule on Thyroid hormones
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of TSH levels
Time Frame: 12 weeks
|
Thyroid Stimulating Hormone-TSH level evaluated at baseline and compare with post treatment levels (after 12 weeks of treatment).
|
12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DC-HLWP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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