Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2021-07-15
2022-03-15
Brief Summary
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Detailed Description
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This Randomized Control interventional three arms Trial will comprise three phases. Patients will be randomized to Zingiber officinale, Carum carvi, L, and Mentha spicata L nutraceuticals or placebo for three months. We will evaluate symptoms assessment, dietary assessment, biochemical and physical analysis i.e. Acid-Fast Bacillus (AFB) for sputum, Chest X-ray (CXR), and Complete Blood Count (CBC) at baseline and after 3 months since the study started.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
Phase2
* The phase will check the impact of selected nutraceuticals on TB patients with dietary counseling and all collected data in Phase1 will be repeated at the end
* 3 selected nutraceuticals Zingiber officinale, Carum carvi, and Mentha spicata will be used against placebo and each placed in a separate group with 50 subjects for 3 months
* Before dispensing treatments, raw material will be processed and encapsulated in prescribed doses in 4 groups after breakfast and dinner T1-Placebo 100mg/d, T2-Zingiber Officinale powder (500mg 2x/d=1000mg/d), T3-Carum powder(1g 2x/d=2g/d), T4-Mentha oil(2% of oil1.5ml 2x/d=30mg/d)
Phase3
\- The impact of withholding the intervention will be studied to observe any change in selected parameters
TREATMENT
NONE
Study Groups
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Exploratory
* After sampling the study population of 200 will be divided into four (04) treatment groups i.e. T1 (Placebo), T2 (Zingiber officinale), T3 (Carum carvi, L), and T4 (Mentha spicata L).
* Each group will be allotted 50 subjects
No interventions assigned to this group
T1
* In the pursuit of scientific understanding, clinical studies play a pivotal role in evaluating the efficacy of treatments. One essential aspect is the inclusion of a placebo group, denoted as the T1 group in this study. Participants in this group will be administered inert material in the form of 100 mg capsules, serving as a baseline for comparison against the active treatment groups.
* Group Designation: T1 Placebo Group
* Intervention: 100 mg capsule containing inert material
* Dosage Frequency: Daily
* Duration: 3 months
* Number of Participants: 50 subjects
* Participants in the T1 Placebo Group are fully informed about the nature of the study, including the possibility of receiving a placebo.
* Informed consent is obtained from each participant, ensuring that they are aware of the study's objectives and the potential for receiving an inactive treatment.
Placebo
Inert Material
T2
* Zingiber officinale, commonly known as ginger, has been of interest for its potential health benefits.
* In this clinical study, the T2 treatment group is designated to receive Zingiber officinale powder.
* Intervention Details:
* Group Designation: T2 Treatment Group
* Intervention: Zingiber officinale powder
* Dosage: 500 mg capsules
* Dosage Frequency: Twice daily
* Total Daily Dosage: 1000 mg
* Administration Timing: After breakfast and dinner
* Duration: 3 months
* Throughout the study duration, data will be systematically collected from participants in the T3 treatment group. This data may include subjective reports, clinical assessments, and laboratory analyses.
Zingier officinale powder
The raw form of Zingiber officinale will be grounded in powder by manual grinding and will be encapsulated.
T3
* Carum carvi, L, commonly known as caraway, is a botanical with a rich history of traditional use. In this clinical study, a treatment group, denoted as T3, is established to investigate the effects of encapsulated Carum carvi, L powder in alleviating the gastrointestinal disturbances among TB patients.
* Intervention Details:
* Generic Name: Carum carvi, L powder
* Dosage Form: Encapsulated
* Dosage: 1 g per capsule
* Frequency: Twice daily
* Total Daily Dosage: 2 g/day
* Administration Timing: After breakfast and dinner
* Duration of Treatment: 3 months
* Throughout the study duration, data will be systematically collected from participants in the T3 treatment group. This data may include subjective reports, clinical assessments, and laboratory analyses.
Carum carvi, L powder
The raw form of Carum carvi, L will be grounded in powder by manual grinding and will be encapsulated.
T4
* Mentha spicata L, commonly known as spearmint, is renowned for its aromatic properties and potential health benefits. In this clinical study, a treatment group, designated as T4, is established to explore the effects of encapsulated Mentha spicata oil.
* Intervention Details:
* Generic Name: Mentha spicata oil
* Dosage Form: Encapsulated
* Concentration: 2% of Spearmint essential oil
* Dosage: 1.5 ml per capsule
* Frequency: Twice daily
* Total Daily Dosage: 30 ml/day
* Administration Timing: After breakfast and dinner
* Duration of Treatment: 3 months
* Throughout the study duration, data will be systematically collected from participants in the T4 treatment group. This data may include subjective reports, clinical assessments, and laboratory analyses.
Mentha spicata oil
Mentha spicata L will be extracted in the form of oil and will be encapsulated.
Washout period
* In this phase impact of withholding the intervention on all parameters will be studied.
* All parameters included in phase1 and 2 will be repeated after one month accordingly, to observe any change in selected parameters after discontinuation of intervention.
No interventions assigned to this group
Interventions
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Placebo
Inert Material
Zingier officinale powder
The raw form of Zingiber officinale will be grounded in powder by manual grinding and will be encapsulated.
Carum carvi, L powder
The raw form of Carum carvi, L will be grounded in powder by manual grinding and will be encapsulated.
Mentha spicata oil
Mentha spicata L will be extracted in the form of oil and will be encapsulated.
Eligibility Criteria
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Inclusion Criteria
* Age group 18-65 years
* Symptoms criteria (Rome IV)
Exclusion Criteria
* Patients registered with extra pulmonary disease
18 Years
65 Years
ALL
No
Sponsors
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Allama Iqbal Open University Islamabad
OTHER
Responsible Party
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Asma Latif
Dietician
Principal Investigators
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Asma Latif, PhD Scholar
Role: PRINCIPAL_INVESTIGATOR
Sheikh Zaid Medical / college.Rahim Yar Khan.Pakistan
Locations
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Sheikh Zayed Medical / college
Rahim Yar Khan, Punjab Province, Pakistan
Countries
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Other Identifiers
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Allama Iqbal Open University.
Identifier Type: -
Identifier Source: org_study_id