Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202209743149100 Date of Approval: 07/09/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A clinical trial to understand the safety and efficacy of an herbal anti-asthmatic medicine prepared from the plant Desmodium adscendens.
Official scientific title Clinical effectiveness and safety of a Desmodium adscendens-based product, Asmodium, as an anti-asthmatic agent.
Brief summary describing the background and objectives of the trial Asthma is a complex, recurrent disease of the airways that causes shortness of breath, wheezing, and cough (particularly at night or early in the morning). It is episodic in nature and usually reversible, either spontaneously or with treatment (Madan et al., 2010). WHO estimates, 250,00 asthma-related deaths are recorded annual from an asthma global prevalence of 1.0 to 18% of the total population of different countries (GINA, 2004). The last few decades have witnessed a rise in the global incidence of asthma particularly in industrialized nations. This phenomenon, termed the ‘asthma epidemic’, has come with an enormous economic burden due to the significant health-care utilization associated with treatment of this condition. Desmodium adscendens is known in the local Akan language of Ghana as Ananse nkante. The plant is an under- shrub with slender thinly pubescent branches. The leaves are alternate with 3 leaflets, the terminal leaflets are ovate to elliptic. The plant is traditionally used in the management of constipation, wounds, dysmenorrhea, hemorrhoids, leucorrhoea, body aches, pains, ovarian inflammations, excessive urination, diarrhoea and bronchial asthma (Mshana et al., 2000; Muanda et al., 2011). Natural products have the potential for good or harm. Likewise, herbal medicines which contain naturally occurring compounds are capable of eliciting various effects on the body. This potential influence on the health of consumers requires that herbal medicinal products be subjected to rigorous scientific testing prior to human use. The aim of this study is thus to evaluate and gather data with respect to the safety and effectiveness of a Ghanaian herbal medicinal product, Asmodium (ASM) formulated from the medicinal herb Desmodium adscendens.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 03/10/2022
Actual trial start date
Anticipated date of last follow up 04/09/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Asmodium 90 ml in three divided dose per day 30 days Asmodium is a Ghanaian herbal medicinal product formulated from the medicinal herb Desmodium adscendens. The product to be assessed is a registered formulation from the Centre for Plant Medicine Research (CPMR) used in the management of allergic diseases. 30
Control Group Budesonide Formoterol Inhaler 160/ 4.5 mcg or 80/ 4.5 mcg Dosage for Budesonide/ Formoterol will be determined based on the age and severity of airway distress. Two weeks Budesonide is a steroid and Formoterol is a long-acting β2-agonist which is considered as a first line intervention for bronchial asthma. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Male and female patients within the age range of 15 - 45 years with severe, moderate or mild asthma defined as an Asthma Score Questionnaire (ASQ) score of 30-20: Severe asthma, 19-10: Moderate asthma, 10-0: Mild asthma. 2. Patients diagnosed with asthma defined as subjects with medical and physical evidence of recurrent episodes of reversible airflow obstruction for at least six (6) months. These signs and symptoms of airway hyper responsiveness include wheezing, cough, chest tightness and shortness of breath (often worse at night). 3. A forced expiratory volume (FEV1) in 1 second of 50% to 90 % of predicted or a 12% increase in the baseline of FEV1 after the administration of a β-agonist. 4. Ability to comply with protocol and complete written informed consent process to participate in the trial. 1. Patients with Chronic Obstructive Pulmonary Disease (COPD). E.g., emphysema and bronchitis. 2. Patients with current and/or recurrent chest infections after a radiograph. 3. Patients who have been diagnosed as status asthmaticus. 4. Patients who are on steroidal drugs and theophylline within the past month. 5. Pregnant and lactating mothers. 6. Patients with chronic liver or kidney disease. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 15 Year(s) 45 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/03/2022 The University of Cape Coast Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
University of Cape Coast Cape Coast PMB Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary measure of efficacy of the treatment will be the resolution of all signs and symptoms of airway hyper responsiveness; example, wheezing, cough, chest tightness, and shortness of breath, an Asthma Score Questionnaire (ASQ) of 0 and increase in FEV1 to 95% and above of the predicted FEV1. Time-to-first use of rescue medications post treatment. Time-to-first use of rescue medictaions post treatment of 63 days.
Secondary Outcome Time-to-first emergency intervention at a health facility. Frequency of rescue use of short acting β-2 agonists. Improvement in the Quality of Life (QOL) of volunteers. The absence of an any untoward effects on the bodily organs as well as side effects (safety evaluation) will be considered as a secondary outcome. Time-to-first emergency intervention at a health facility beofre or during the 63 days.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre for Plant Medicine Research Lynns Avenue Mampong Akuapem 73 Ghana
Tetteh Quarshie Memorial Hospital Hosptial Avenue Mampong Akuapem 26 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Ronald Yeboah AMURSK ST Akropong Akuapem 73 Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ronald Yeboah AMURSK ST Akropong Akuapem 73 Ghana Individual
COLLABORATORS
Name Street address City Postal code Country
Kwesi Prah Thomford PhD UCC Cape Coast Ghana
Frank Dzifa Kpesenu Tetteh Quarshie Memorial Hospital Bungalow Mampong Akuapem 26 Ghana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kwesi Prah Thomford kwesi.thomford@ucc.edu.gh +233273900517 Cape Coast
City Postal code Country Position/Affiliation
Cape Coast Ghana Lecturer at Department of Pharmacognosy and Herbal Medicine School of Pharmacy and Pharmaceutical Sciences University of Cape Coast
Role Name Email Phone Street address
Public Enquiries Ronald Yeboah ryeboah@cpmr.org.gh +233242516649 AMURSK ST
City Postal code Country Position/Affiliation
Akropong Akuapem 73 Ghana Senior Medical Herbalist at Clinical Research Department of the Centre for Plant Medicine Research
Role Name Email Phone Street address
Scientific Enquiries Ama Thomford ama.thomford@ucc.edu.gh +233272430485 UCC
City Postal code Country Position/Affiliation
Cape Coast Ghana Lecturer at Department of Biomedical Sciences University of Cape Coast
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All data collected from participants and used in the final analysis will be available to the public after a process of deidentifying them. The study protocol, consent forms and related data collection tools will be accessible. Clinical Study Report,Informed Consent Form,Study Protocol Data will be available for secondary use 6 months after completion of the study. Individuals with an interest in the data will need to apply to the Ethics committee of the facility. All applications will be reviewed and each application accepted based on its merit to society. Assurances would need to be provided by applicants about non commercial use and third party usage of the information.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information