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

Parkinson Disease Clinical Trial

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

Status Recruiting

Clinical Trial 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

Clinical Trial 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

1. 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. ;

Related Conditions & MeSH terms

• Neurodegenerative Diseases
• Parkinson Disease

• NCT number: NCT05696665
• Study type: Interventional
• Source: Jinnah Postgraduate Medical Centre
• Contact: Fizzah Ali, MBBS, MPhil
• Phone: +923333235882
• Email: fizzah.saqib@gmail.com
• Status: Recruiting
• Phase: N/A
• Start date: July 5, 2022
• Completion date: July 2023