Investigating the beneficial effect of Dracocephalum kotschyi capsule in asthmatic patients.

Evaluation of clinical effects of capsule prepared from the hydroalcoholic extract of Dracocephalum kotschyi in comparison with placebo for control of clinical symptoms in patients suffering from asthma- a cross over clinical trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200810048352N2

Enrollment

Registered

2024-11-18

Start date

2024-11-21

Completion date

Unknown

Last updated

2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma. Moderate persistent asthma, uncomplicated

Interventions

Intervention 1: Intervention group: receiving Dracocephalum kotschyi capsule (50mg) three times daily accompanied with inhalation corticosteroid as well as routine inhalation bronchodilator for two

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age18 to 65 years old forced expiratory volume in one second (FEV1) above 40% mean peak expiratory flow rate (PEFR) of 75% of its predicted value Stop using bronchodilators other than salbutamol

Exclusion criteria

Exclusion criteria: Pregnancy and breastfeeding Patients with other systemic disease (other than asthma) Taking oral corticosteroids changing in dosage of inhalational corticosteroid

Design outcomes

Primary

Measure	Time frame
Peak expiratory flow rate (PEFR). Timepoint: morning and evening peak expiratory flow rate (PEFR) measurements by the patient. Method of measurement: Using pocket peak flow meter.;Shortness of breath. Timepoint: before and during the study. Method of measurement: A diary self-assessment form (ACT) will be used to record shortness of breath by the patient.;Bronchodilator requirement. Timepoint: before and during the study. Method of measurement: A diary self-assessment form (ACT) will be used to record inhalational bronchodilator usage.;Asthma symptoms (wheezing, coughing, chest tightness, or pain)Timepoint. Timepoint: before and during the study. Method of measurement: A diary self-assessment form (ACT) will be used to record inhalational bronchodilator usage.	—

Measure

Time frame

Peak expiratory flow rate (PEFR). Timepoint: morning and evening peak expiratory flow rate (PEFR) measurements by the patient. Method of measurement: Using pocket peak flow meter.;Shortness of breath. Timepoint: before and during the study. Method of measurement: A diary self-assessment form (ACT) will be used to record shortness of breath by the patient.;Bronchodilator requirement. Timepoint: before and during the study. Method of measurement: A diary self-assessment form (ACT) will be used to record inhalational bronchodilator usage.;Asthma symptoms (wheezing, coughing, chest tightness, or pain)Timepoint. Timepoint: before and during the study. Method of measurement: A diary self-assessment form (ACT) will be used to record inhalational bronchodilator usage.

—

Secondary

Measure	Time frame
Quality of Life. Timepoint: before and during the study. Method of measurement: A dairy self-assessment form (ACT) will be used to record how much of the time asthma symptoms keep the patient from getting as much done at work, school or at home.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Hassan Sadraei

Esfahan University of Medical Sciences

sadraei@pharm.mui.ac.ir+98 31 3792 7086

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026