Effect of Silymarin as Add on Therapy on Oxidative Stress, Pulmonary Function and Quality of Life in Stable COPD Patients.

NCT07123922 | Enrolling By Invitation DMC

• 1 other identifier: BSMMU/2025/4267
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if Silymarin works to reduce oxidative stress, improve pulmoary function and quality of life in stable COPD patients. It will also learn about the safety of drug Silymarin. The main questions it aims to answer are: Does drug Silymarin reduce oxidative stress, improve pulmonary function and quality of life in stable COPD patients? What medical problems do participants have when taking drug Silymarin? Researchers will compare Silymarin to a placebo (a look-alike substance that contains no drug) to see if Silymarin works to treat COPD. Participants will: Take Silymarin or a placebo thrice daily every day for 3 months. Baseline and 3 months after plasma Malondealdehyde, erythrocyte Glutathione , FEV1, SGRQ-C score will be monitored.

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Outcome Measures

Primary Outcomes (2)

• Oxidative stress marker plasma MDA

  Comparison of plasma malondialdehyde (MDA) between control and intervention arms at baseline and after 12 weeks of treatment.

  12 weeks

• Oxidative stress marker erythrocyte glutathione

  Comparison of erythrocyte glutathione concentration (GSH) between control and intervention arms at baseline and after 12 weeks of treatment.

  12 weeks

Secondary Outcomes (2)

• Pulmonary function

  12 weeks

• SGRQ-C score

  12 weeks

Study Arms (2)

Silymarin

EXPERIMENTAL

Participants received Cap. Silymarin 140 mg orally thrice daily for 12 weeks

Dietary Supplement: Silymarin

Placebo

PLACEBO COMPARATOR

Participants received Silymarin placebo capsule matching Silymarin orally thrice daily for 12 weeks

Dietary Supplement: Placebo

Interventions

Silymarin DIETARY_SUPPLEMENT

Participants received Silymarin 140 mg capsule orally thrice daily for 12 weeks

Silymarin

Placebo DIETARY_SUPPLEMENT

Participants received Silymarin placebo capsule thrice daily for 12 weeks

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed case of COPD according to GOLD guideline (post bronchodilator FEV1/FVC \< 0.7).
• Age 40-80 years
• No exacerbation or hospitalization due to exacerbation in the last 1 month.

You may not qualify if:

• COPD exacerbation
• Presence of other respiratory diseases like asthma, bronchiectasis, interstitial lung disease, tuberculosis or lung cancer
• Diagnosed case of diabetes mellitus, liver disease, heart disease, kidney stones and disease, hyperparathyroidism, other malignancies
• Use of other antioxidant drugs like Vitamin C, E, N acetylcysteine within last 1 months
• Known hypersensitivity to Silymarin

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

BSMMU

Dhaka, 1000, Bangladesh

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Silymarin

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Flavonolignans; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sanjida Akter, MD, Bangabandhu Sheikh Mujib Medical University, Dhaka.

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: August 14, 2025
• Study Start: June 20, 2025
• Primary Completion: November 15, 2025
• Study Completion: December 31, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

BA (1)