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Anti-Tuberculosis Treatment (ATT) is one of the effective treatments of tuberculosis but the use of drugs for a long time put an adverse effect on the gut and other organs of the body. Nutraceuticals are the cheapest natural sources with therapeutic effects. These natural medicines help in alleviating gastrointestinal disturbances. This study will be conducted to overcome gastrointestinal issues with the help of nutraceuticals, which are more acceptable by the majority and have no side effects.
The aim of this study will be to evaluate if Zingiber officinale, Carum carvi, L, and Mentha spicata L nutraceuticals can help in alleviating gastrointestinal disturbances in subjects which are more acceptable by the majority and have no side effects.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exploratory | No Intervention |
| |
| T1 | Experimental |
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| T2 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | Inert Material |
| |
| Zingier officinale powder |
| Measure | Description | Time Frame |
|---|---|---|
| --GIT disturbances | GIT disturbences will be assessed through ROME IV including abdominal pain, bloating, vomiting and nausea in Phase 1. | "1 Month" at study commencement (Phase 1) |
| GIT disturbances | GIT disturbences will be assessed through ROME IV including abdominal pain, bloating, vomiting and nausea in Phase 2 after completion of three-month intervention. | Termination of Phase 2 (Intervention period) "3 Months" |
| GIT disturbances | GIT disturbences will be assessed through ROME IV including abdominal pain, bloating, vomiting and nausea in Phase 3 which is wash out time. | Termination of phase 3 (Washout period) "1 Month" |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index | Measurements will be taken in triplicate. Height will be measured to the nearest 0.5 cm with a stadiometer (or knee height, ulnar length or arm span [demispan] for those persons unable to stand fully erect); body weight will be measured to the nearest 0.1 kg. | "through study completion, an average of 9 months" |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Asma Latif, PhD Scholar | Sheikh Zaid Medical / college.Rahim Yar Khan.Pakistan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheikh Zayed Medical / college | Rahim Yar Khan | Punjab Province | 64200 | Pakistan |
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| ID | Term |
|---|---|
| D014397 | Tuberculosis, Pulmonary |
| D004066 | Digestive System Diseases |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
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Phase1 - 200 population size will be divided into 4 treatment groups
Phase2
Phase3
- The impact of withholding the intervention will be studied to observe any change in selected parameters
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| T3 | Experimental |
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| T4 | Experimental |
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| Washout period | No Intervention |
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| Dietary Supplement |
The raw form of Zingiber officinale will be grounded in powder by manual grinding and will be encapsulated. |
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| Carum carvi, L powder | Dietary Supplement | The raw form of Carum carvi, L will be grounded in powder by manual grinding and will be encapsulated. |
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| Mentha spicata oil | Dietary Supplement | Mentha spicata L will be extracted in the form of oil and will be encapsulated. |
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| A self-designed / pretested questionnaire |
will be used to collect data on other determinants that affect patients regarding disease history, and dietary history. Agarwal Socio-economic status (SES) performa will be used. |
| "through study completion, an average of 9 months" |
| Acid-Fast Bacillus (sputum) | sample will be taken at time of enrollment in study to make diagnosis of Tuberculosis | "through study completion, an average of 9 months" |
| Chest X-ray (CXR) | Phase 1 in which subjects will be enrolled and their CXR will be taken as criteria for diagnosis of TB | "1 Day" at study commencement (Phase 1) |
| Complete blood count (CBC) | Phase 1 in which subjects will be enrolled and their CBC will be taken as criteria for diagnosis of TB | "1 Day" at study commencement (Phase 1) |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |