Clinical Efficacy of Darqeen Capsule for the Management o... | NCT06826248

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

NCT06826248

Sponsor

Hamdard University

Status

Active, not recruiting

Last Update Posted

Feb 13, 2025Actual

Enrollment

50Actual

Phase

Early Phase 1

Conditions

Hypothyroidism

Interventions

Darqeen Capsule

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2, 2024Actual

Primary Completion Date

Oct 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Feb 1, 2025

First Submission Date that Met QC Criteria

Feb 12, 2025

First Posted Date

Feb 13, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2025

Last Update Posted Date

Feb 13, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single Arm	Other		Drug: Darqeen Capsule

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Darqeen Capsule	Drug	Effect of Darqeen capsule on Thyroid hormones	Single Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Females

Minimum Age

15 Years

Maximum Age

45 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shifa Ul Mulk Memorial Hospital-Hamdard University		Karachi	Sindh		Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

will be share to ethical body

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007037	Hypothyroidism
D007247	Infertility, Female

Ancestor Terms

ID	Term
D013959	Thyroid Diseases
D004700	Endocrine System Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided