AsthmaWISTANCT07787507
Withania Somnifera for Moderate-to-Severe Persistent Asthma
A study testing Withania somnifera Root Powder and Standard Asthma Treatment in people with Asthma, run by Aligarh Muslim University at 1 site in India.
Trial summary
This randomized, double-blind, placebo-controlled study evaluated Withania somnifera root powder as a complementary therapy in adults with moderate-to-severe persistent asthma receiving standard asthma treatment. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Asthma
- What is being tested?
- Withania somnifera Root Powder and Standard Asthma Treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteIndia
- Study dates
- 15 Feb 2026to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 50 years Moderate to severe persistent asthma Non-smokers Receiving standard asthma medications for no more than one month
Who cannot join
- Recent respiratory tract infection Pregnant or lactating women Serious comorbid conditions Hospitalization within the previous one month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on Anti-oxidative and Anti-Inflammatory Effects of Certain Herbs for Inflammatory Lung Diseases
This randomized, double-blind, placebo-controlled study evaluated Withania somnifera root powder as a complementary therapy in adults with moderate-to-severe persistent asthma receiving standard asthma treatment. Participants were assigned to standard treatment alone, standard treatment plus placebo, or standard treatment plus Withania somnifera root powder for 10 weeks. Lung function, asthma control, quality of life, systemic oxidative stress, and inflammatory and allergic biomarkers were assessed before and after the intervention to evaluate the potential additional benefits of Withania somnifera in asthma management.
Read the detailed description
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.
- Conditions
- Asthma
- Being tested
- Withania somnifera Root Powder, Starch Placebo Capsules, Standard Asthma Treatment
- Keywords
- Withania somnifera, Ashwagandha, Complementary Therapy, Moderate-to-Severe Persistent Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Withania somnifera Root PowderDietary supplement
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.
Starch Placebo CapsulesOther
Starch placebo capsules were administered orally for 10 weeks in addition to standard asthma treatment.
Standard Asthma TreatmentDrug
Standard asthma treatment included inhaled corticosteroid (fluticasone) and long-acting beta-agonist therapy according to the treating physician's prescription.
| Study group | Role | What they receive |
|---|---|---|
| Withania somnifera Treatment Group | Experimental | Participants received standard asthma treatment plus Withania somnifera root powder capsules, 300 mg orally twice daily for 10 weeks. Receives: Dietary Supplement: Withania somnifera Root Powder; Drug: Standard Asthma Treatment |
| Placebo Group | Placebo comparator | Participants received standard asthma treatment plus starch placebo capsules orally for 10 weeks. Receives: Other: Starch Placebo Capsules; Drug: Standard Asthma Treatment |
| Control Group | Active comparator | Participants received standard conventional asthma treatment, including inhaled corticosteroid (fluticasone) and long-acting beta-agonist therapy, according to the treating physician's prescription. Receives: Drug: Standard Asthma Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FEV1 Percent Predicted
Forced expiratory volume in one second (FEV1) percent predicted was measured by spirometry to assess lung function before and after the intervention.
Measured: Baseline and after 10 weeks of intervention
Secondary outcomes (1)
Change in Total Antioxidant Capacity
Total antioxidant capacity of plasma was assessed using the ferric reducing antioxidant power (FRAP) assay before and after the intervention.
Measured: Baseline and after 10 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start15 Feb 2026
- Primary completion15 Jun 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aligarh Muslim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Priyam Singh, Aligarh Muslim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07787507
- Sponsor's protocol ID
- IECJNMC/628
- Acronym
- WISTA
- Status last verified
- Aug 2026
- First submitted
- 23 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because no prospective IPD-sharing plan was established for this study. Participant-level data will be maintained confidentially in accordance with institutional and ethical requirements.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Anti-oxidative and Anti-Inflammatory Effects of Certain Herbs for Inflammatory Lung Diseases
- ClinicalTrials.gov ID
- NCT07787507
- Acronym / sponsor ID
- WISTA / IECJNMC/628
- Conditions
- Asthma
- Keywords
- Withania somnifera, Ashwagandha, Complementary Therapy, Moderate-to-Severe Persistent Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Aligarh Muslim UniversityUniversity, hospital or other
- Study start
- 15 Feb 2026 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 26 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized, double-blind, placebo-controlled study evaluated Withania somnifera root powder as a complementary therapy in adults with moderate-to-severe persistent asthma receiving standard asthma treatment. Participants were assigned to standard treatment alone, standard treatment plus placebo, or standard treatment plus Withania somnifera root powder for 10 weeks. Lung function, asthma control, quality of life, systemic oxidative stress, and inflammatory and allergic biomarkers were assessed before and after the intervention to evaluate the potential additional benefits of Withania somnifera in asthma management.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Withania somnifera Treatment Group | Experimental | Dietary Supplement: Withania somnifera Root Powder, Drug: Standard Asthma TreatmentParticipants received standard asthma treatment plus Withania somnifera root powder capsules, 300 mg orally twice daily for 10 weeks. |
| Placebo Group | Placebo comparator | Other: Starch Placebo Capsules, Drug: Standard Asthma TreatmentParticipants received standard asthma treatment plus starch placebo capsules orally for 10 weeks. |
| Control Group | Active comparator | Drug: Standard Asthma TreatmentParticipants received standard conventional asthma treatment, including inhaled corticosteroid (fluticasone) and long-acting beta-agonist therapy, according to the treating physician's prescription. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age 18 to 50 years Moderate to severe persistent asthma Non-smokers Receiving standard asthma medications for no more than one month
Key exclusion criteria (1 listed)
- Recent respiratory tract infection Pregnant or lactating women Serious comorbid conditions Hospitalization within the previous one month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Withania somnifera Root PowderWithania 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. | Dietary supplement | Withania somnifera Treatment Group |
| Starch Placebo CapsulesStarch placebo capsules were administered orally for 10 weeks in addition to standard asthma treatment. | Other | Placebo Group |
| Standard Asthma TreatmentStandard asthma treatment included inhaled corticosteroid (fluticasone) and long-acting beta-agonist therapy according to the treating physician's prescription. | Drug | Control Group, Placebo Group, Withania somnifera Treatment Group |
Primary outcome
Change in FEV1 Percent Predicted
Time frame: Baseline and after 10 weeks of intervention
Forced expiratory volume in one second (FEV1) percent predicted was measured by spirometry to assess lung function before and after the intervention.
1 secondary outcome
Change in Total Antioxidant Capacity
Time frame: Baseline and after 10 weeks of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because no prospective IPD-sharing plan was established for this study. Participant-level data will be maintained confidentially in accordance with institutional and ethical requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Withania somnifera Root Powder and Standard Asthma Treatment in people with Asthma, run by Aligarh Muslim University at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in FEV1 Percent Predicted (time frame: Baseline and after 10 weeks of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.