SAFCHEMRxPar: Role of Saffron and Chamomile in the Management of Parkinson's Disease

Sponsor

Jinnah Postgraduate Medical Centre (Other)

Overall Status

Recruiting

CT.gov ID

NCT05696665

Collaborator

Aga Khan University Hospital, Pakistan (Other), Liaquat National Hospital & Medical College (Other)

120

Enrollment

Location

Arms

11.9

Anticipated Duration (Months)

10.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In multitudinous preclinical studies, Saffron and Chamomile are found effective in treating PD. They can mitigate the neurodegenerative progression of the disease by curtailing dopaminergic and neuronal loss and by inhibiting alpha-synuclein aggregation. They also possess antioxidant and anti-inflammatory activities. The synergism of both drugs can manage Parkinson's disease and related neurological disorders although, clinical trials are needed for further elaboration. Therefore, the purpose of the study is to evaluate the effects of Saffron and Chamomile and their active compounds in treating Parkinson's disease. This combination may change psychometric measures (MDS-Unified Parkinson's Disease Rating Scale), biomarkers (including Alpha-synuclein), and oxidative stress-related to Parkinson's disease. This combination along with conventional therapy might be beneficial in managing patients with Parkinson's disease

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease Neurodegenerative Diseases	Other: conventional therapy Drug: Saffron and Chamomile Drug: Crocin and Apigenin	N/A

Detailed Description

Parkinson's disease(PD) is a distinctive clinical disorder with a multifactorial range of etiology and symptoms. This neurodegenerative disease is spreading at exponent rates. It can impact individuals enormously. As a degenerative disease, its progression can span decades. The disease has profound repercussions for caregivers and is also a socio-economic burden for society SAFFRON Saffron is a spice obtained from the stigmas of the Crocus sativus L flower, grown extensively in Iran and other parts of the world, including Greece and India. According to current data, saffron cultivation and usage date back approximately 3000 years, although the oldest records of this plant date back to the Assyrian era.

Saffron is a perennial plant that grows to a height of 10 to 30 cm. Numerous leaves branch out from the bulb's center, culminating in two to three blooms. The color is determined by the amount of lycopene and carotenoid contained inside a three-branched stigma stigma.

Saffron contains 5% fat, 5% minerals, 10% moisture , 12% protein, 63% sugars and 5% crude fiber. Stigmas contain around 150 volatile chemicals, including terpenes, and alcohol, along with their esters. Three important bioactive components in Saffron are crocin, safranal, and picrocrocin, which are responsible for Saffron's taste, unique color r. Saffron's bitter flavor is created by picrocrocin, which eventually transforms into safranal. Additionally, lycopene, zeaxanthin, carotene, vitamins including thiamine and riboflavin are active components Saffron contains about 150 compounds, however the most physiologically active are two carotenoids called crocin and crocetin .Both of these compounds have been evaluated pharmacokinetically in animal and human research. According to pharmacokinetic studies Crocin is not accessible in the bloodstream as it is after oral intake but converted to crocetin in the colon. Additionally, it may cross the blood-brain barrier and enter the central nervous system through passive transcellular diffusion, making it beneficial in neurodegenerative illnesses.

CHAMOMILE Matricaria recutita chamomilla is an annual plant native to Europe and Asia with branching, tall, and smooth stems. Apigenin, apigenin-7-O-glucoside, luteolin, and luteolin-7-O-glucoside, terpene bisabolol ,caffeic acid, farnesene, chamazulene, chlorogenic acid flavonoids (apigenin, quercetin, , patuletin and luteolin), and coumarin are the chemical components found in this plant.

Pharmacological activities German chamomile is beneficial for treating stomachaches, IBS, and sleeplessness. It has anti-inflammatory, antibacterial, and relaxing properties. Additionally, it has acaricidal effects. Several animal studies have revealed that this herb has neuroprotective,anxiolytic, antimutagenic, cholesterol-lowering, wound healing, and antidiabetic effects. Chamomile was shown to have weak antibacterial and antioxidant capabilities, but substantial antiplatelet and anticarcinoma activities in in vitro experiments.

Rationale of the study :

In various preclinical studies role of saffron and chamomile is found effective in treating Parkinson disease. Their neuroprotective and antioxidant effects are also widely known. Although, efficacy of this combination in treating Parkinson disease as a clinical trial is yet to be analyzed .Therefore, this clinical trial is designed to determine the effects of saffron and chamomile as combination in compared to approved pharmacotherapy

Aim :

To study the effects of Saffron and Chamomile in the treatment of with reference to psychometric biochemical , and Insilco measures.

HYPOTHESIS Null Hypothesis There is no beneficial effects of Saffron and chamomile in the treatment of Parkinson disease Alternative Hypothesis Saffron and chamomile have efficacy in the treatment of Parkinson disease

AIM & OBJECTIVES

To evaluate and compare :

clinical efficacy of saffron and chamomile in the management of Parkinson disease.
the effects of saffron and chamomile on plasma biomarkers in the management of Parkinson disease.
the antioxidant effects of saffron and chamomile in the management of Parkinson disease.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

GROUP A Conventional drugs only 40 GROUP B:Conventional drugs +1000 mg chamomile 30 mg saffron in a capsule form GROUP C:GROUP C Conventional drugs +500mgApigenin +30mg Crocin 40GROUP A Conventional drugs only 40 GROUP B:Conventional drugs +1000 mg chamomile 30 mg saffron in a capsule form GROUP C:GROUP C Conventional drugs +500mgApigenin +30mg Crocin 40

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Role of Saffron and Chamomile and Their Active Compounds in the Management of Parkinson Disease in the Context of Psychometric and Biochemical Measures

Actual Study Start Date :

Jul 5, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group A conventional therapy only	Other: conventional therapy Patients will be kept on conventional therapy and no added drugs will be given
Experimental: Group B conventional therapy +500 mg chamomile 15 mg saffron twice daily	Drug: Saffron and Chamomile Patients will be given saffron and chamomile in capsule formulation twice daily
Experimental: Group C conventional therapy +500mgApigenin +30mg Crocin once daily	Drug: Crocin and Apigenin Active ingredients of saffron(Crocin) and Chamomile(Apigenin) will be given in capsule formultaion once daily

Arm

Intervention/Treatment

Active Comparator: Group A

conventional therapy only

Other: conventional therapy

Patients will be kept on conventional therapy and no added drugs will be given

Experimental: Group B

conventional therapy +500 mg chamomile 15 mg saffron twice daily

Drug: Saffron and Chamomile

Patients will be given saffron and chamomile in capsule formulation twice daily

Experimental: Group C

conventional therapy +500mgApigenin +30mg Crocin once daily

Drug: Crocin and Apigenin

Active ingredients of saffron(Crocin) and Chamomile(Apigenin) will be given in capsule formultaion once daily

Outcome Measures

Primary Outcome Measures

Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale [4months]
The MDS-UPDRS can be used to evaluate various aspects of Parkinson's disease, including non-motor and motor experiences of daily living and motor complications. It includes a motor evaluation and characterizes the extent and burden of disease across various populations. All items have five response options with uniform anchors of 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.Each parkinsonian sign or symptom is rated on a 5-point Likert-type scale (ranging from 0 to 4), with higher scores indicating more severe impairment. The maximum total UPDRS score is 199, indicating the worst possible disability from PD
Levels of Alpha-synuclein and Human Neurofilament Light [4 months]
levels of Alpha-synuclein and Human Neurofilament Light will be measured on day 0 and last day of trial using Elisa
Level of antioxidant:Superoxide Dismutase (SOD) [4 months]
levels of Superoxide Dismutase (SOD) will be measured on day 0 and last day of trial

Secondary Outcome Measures

Incidence of treatment -Emergent Adverse Events(Safety and Evaluation) [4 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

• All diagnosed patients aged 40-years and above of either sex will be included
Diagnosis will be based on the UK Parkinson Disease Society Brain Bank Clinical Diagnostic Criteria reported by neurophysicians.