Withania Somnifera for Moderate-to-Severe Persistent Asthma (WISTA)
Study on Anti-oxidative and Anti-Inflammatory Effects of Certain Herbs for Inflammatory Lung Diseases
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This randomized, double-blind, placebo-controlled clinical study was conducted at Jawaharlal Nehru Medical College, Aligarh Muslim University, Aligarh, India. Adults aged 18-50 years with moderate-to-severe persistent asthma were included in the study. Eligible participants were non-smokers and were receiving standard asthma medication. Patients with recent respiratory tract infection, pregnancy or lactation, serious comorbid conditions, or hospitalization within the previous month were excluded.
Participants were allocated using computer-generated randomization to three groups: a control group receiving conventional asthma treatment, a placebo group receiving conventional treatment plus starch capsules, and a Withania somnifera-treated group receiving conventional treatment plus Withania somnifera root powder capsules. The Withania somnifera intervention consisted of 300 mg root powder administered orally twice daily for 10 weeks.
Clinical assessments were performed at baseline and after the 10-week intervention. Lung function was evaluated by spirometry using FEV1 percent predicted, FVC percent predicted, and the FEV1/FVC ratio. Asthma control was assessed using the Asthma Control Test, and quality of life was evaluated using the Asthma Quality of Life Questionnaire.
Blood samples were collected for assessment of systemic oxidative stress, inflammation, and allergic markers. Evaluations included total antioxidant capacity, malondialdehyde, total sulfhydryl groups, neutrophil and eosinophil percentages, and circulating IL-4, IL-8, IL-13, IL-17A, and IgE levels. Plasma samples were stored at -80°C until laboratory analysis.
The study was reviewed and approved by the Institutional Ethical Committee of Jawaharlal Nehru Medical College, Aligarh Muslim University (IECJNMC/628), and written informed consent was obtained from the participants.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Uttar Pradesh
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Aligarh, Uttar Pradesh, Indien, 202001
- Aligarh Muslim University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Age 18 to 50 years Moderate to severe persistent asthma Non-smokers Receiving standard asthma medications for no more than one month
Exclusion Criteria:
- Recent respiratory tract infection Pregnant or lactating women Serious comorbid conditions Hospitalization within the previous one month
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Withania somnifera Treatment Group
Participants received standard asthma treatment plus Withania somnifera root powder capsules, 300 mg orally twice daily for 10 weeks.
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Withania somnifera root powder was administered orally in capsule form at a dose of 300 mg twice daily (total daily dose 600 mg) for 10 weeks, in addition to standard asthma treatment.
Standard asthma treatment included inhaled corticosteroid (fluticasone) and long-acting beta-agonist therapy according to the treating physician's prescription.
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Placebo komparator: Placebo Group
Participants received standard asthma treatment plus starch placebo capsules orally for 10 weeks.
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Standard asthma treatment included inhaled corticosteroid (fluticasone) and long-acting beta-agonist therapy according to the treating physician's prescription.
Starch placebo capsules were administered orally for 10 weeks in addition to standard asthma treatment.
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Aktiv komparator: Control Group
Participants received standard conventional asthma treatment, including inhaled corticosteroid (fluticasone) and long-acting beta-agonist therapy, according to the treating physician's prescription.
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Standard asthma treatment included inhaled corticosteroid (fluticasone) and long-acting beta-agonist therapy according to the treating physician's prescription.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in FEV1 Percent Predicted
Tidsramme: Baseline and after 10 weeks of intervention
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Forced expiratory volume in one second (FEV1) percent predicted was measured by spirometry to assess lung function before and after the intervention.
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Baseline and after 10 weeks of intervention
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Total Antioxidant Capacity
Tidsramme: Baseline and after 10 weeks of intervention
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Total antioxidant capacity of plasma was assessed using the ferric reducing antioxidant power (FRAP) assay before and after the intervention.
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Baseline and after 10 weeks of intervention
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IECJNMC/628
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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