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

Parkinson Disease Clinical Trial

— SAFCHEMRxPar  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05696665
• Other study ID #: F.2-81/2022-GENL/104/JPMC
• Secondary ID: 9447Dr Saara Ahm
• Status: Recruiting
• Phase: N/A
• Start date: July 5, 2022
• Est. completion date: July 2023

Study information

• Verified date: January 2023
• Source: Jinnah Postgraduate Medical Centre
• Contact: Fizzah Ali, MBBS, MPhil
• Phone: +923333235882
• Email: fizzah.saqib[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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.

Exclusion Criteria:

• • Patients with atypical Parkinsonism will be excluded.

• Patients with uncontrolled comorbidities will also be excluded.

Related Conditions & MeSH terms

• Neurodegenerative Diseases
• Parkinson Disease

Intervention

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

Drug:
• Saffron and Chamomile
Patients will be given saffron and chamomile in capsule formulation twice daily
• Crocin and Apigenin
Active ingredients of saffron(Crocin) and Chamomile(Apigenin) will be given in capsule formultaion once daily

Locations

Country	Name	City	State
Pakistan	Jinnah Postgraduate Medical Centre (JPMC),	Karachi	Sindh

Sponsors (3)

Lead Sponsor	Collaborator
Jinnah Postgraduate Medical Centre	Aga Khan University Hospital, Pakistan, Liaquat National Hospital & Medical College

Country where clinical trial is conducted

Pakistan, 

References & Publications (9)

Anusha C, Sumathi T, Joseph LD. Protective role of apigenin on rotenone induced rat model of Parkinson's disease: Suppression of neuroinflammation and oxidative stress mediated apoptosis. Chem Biol Interact. 2017 May 1;269:67-79. doi: 10.1016/j.cbi.2017.0 — View Citation

De Monte C, Carradori S, Chimenti P, Secci D, Mannina L, Alcaro F, Petzer A, N'Da CI, Gidaro MC, Costa G, Alcaro S, Petzer JP. New insights into the biological properties of Crocus sativus L.: chemical modifications, human monoamine oxidases inhibition an — View Citation

Ghasemi Tigan M, Ghahghaei A, Lagzian M. In-vitro and in-silico investigation of protective mechanisms of crocin against E46K alpha-synuclein amyloid formation. Mol Biol Rep. 2019 Aug;46(4):4279-4292. doi: 10.1007/s11033-019-04882-9. Epub 2019 May 20. — View Citation

Haeri P, Mohammadipour A, Heidari Z, Ebrahimzadeh-Bideskan A. Neuroprotective effect of crocin on substantia nigra in MPTP-induced Parkinson's disease model of mice. Anat Sci Int. 2019 Jan;94(1):119-127. doi: 10.1007/s12565-018-0457-7. Epub 2018 Aug 29. — View Citation

Inoue E, Shimizu Y, Masui R, Hayakawa T, Tsubonoya T, Hori S, Sudoh K. Effects of saffron and its constituents, crocin-1, crocin-2, and crocetin on alpha-synuclein fibrils. J Nat Med. 2018 Jan;72(1):274-279. doi: 10.1007/s11418-017-1150-1. Epub 2017 Nov 1 — View Citation

Inoue E, Suzuki T, Shimizu Y, Sudo K, Kawasaki H, Ishida N. Saffron ameliorated motor symptoms, short life span and retinal degeneration in Parkinson's disease fly models. Gene. 2021 Oct 5;799:145811. doi: 10.1016/j.gene.2021.145811. Epub 2021 Jul 2. — View Citation

Mohammadzadeh L, Ghasemzadeh Rahbardar M, Razavi BM, Hosseinzadeh H. Crocin Protects Malathion-Induced Striatal Biochemical Deficits by Inhibiting Apoptosis and Increasing alpha-Synuclein in Rats' Striatum. J Mol Neurosci. 2022 May;72(5):983-993. doi: 10. — View Citation

Rajaei Z, Hosseini M, Alaei H. Effects of crocin on brain oxidative damage and aversive memory in a 6-OHDA model of Parkinson's disease. Arq Neuropsiquiatr. 2016 Sep;74(9):723-729. doi: 10.1590/0004-282X20160131. — View Citation

Siddique YH, Jyoti S. Alteration in biochemical parameters in the brain of transgenic Drosophila melanogaster model of Parkinson's disease exposed to apigenin. Integr Med Res. 2017 Sep;6(3):245-253. doi: 10.1016/j.imr.2017.04.003. Epub 2017 Apr 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale	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	4months
Primary	Levels of Alpha-synuclein and Human Neurofilament Light	levels of Alpha-synuclein and Human Neurofilament Light will be measured on day 0 and last day of trial using Elisa	4 months
Primary	Level of antioxidant:Superoxide Dismutase (SOD)	levels of Superoxide Dismutase (SOD) will be measured on day 0 and last day of trial	4 months
Secondary	Incidence of treatment -Emergent Adverse Events(Safety and Evaluation)		4 months

External Links

•   Crocin Reverses Depression-Like Behavior in Parkinson
•   efficacy of parkinson disease