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

NCT ID: NCT05696665

Last Updated: 2023-01-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-05
• Study Completion Date: 2023-07-31

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

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

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.

Conditions

Parkinson Disease; Neurodegenerative Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A

conventional therapy only

Group Type: ACTIVE_COMPARATOR

conventional therapy

Intervention Type: OTHER

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

Group B

conventional therapy +500 mg chamomile 15 mg saffron twice daily

Group Type: EXPERIMENTAL

Saffron and Chamomile

Intervention Type: DRUG

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

Group C

conventional therapy +500mgApigenin +30mg Crocin once daily

Group Type: EXPERIMENTAL

Crocin and Apigenin

Intervention Type: DRUG

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

Interventions

conventional therapy

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

Intervention Type: OTHER

Saffron and Chamomile

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

Intervention Type: DRUG

Crocin and Apigenin

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aga Khan University Hospital, Pakistan

OTHER

Sponsor Role: collaborator

Liaquat National Hospital & Medical College

OTHER

Sponsor Role: collaborator

Jinnah Postgraduate Medical Centre

OTHER_GOV

Sponsor Role: lead

Responsible Party

Fizzah Ali

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fizzah Ali, MBBS,MPhil

Role: PRINCIPAL_INVESTIGATOR

Liaquat National hospital and Medical college

Locations

Jinnah Postgraduate Medical Centre (JPMC),

Karachi, Sindh, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Fizzah Ali, MBBS, MPhil

Role: CONTACT

fizzah.saqib@gmail.com

+923333235882

Fizzah Mudassir, MBBS, PhD

Role: CONTACT

saara.mudassir@aku.edu

+923343448258

Facility Contacts

Fizzah Ali, MPhill

Role: primary

fizzah.saqib@gmail.com

03333235882

Saara Mudassir, PhD

Role: backup

saara.muddasir@aku.edu

0333 3448258

References

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.

Reference Type: RESULT

PMID: 27706421 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30159851 (View on PubMed)

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 17.

Reference Type: RESULT

PMID: 29147836 (View on PubMed)

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.

Reference Type: RESULT

PMID: 34224829 (View on PubMed)

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 and molecular modeling studies. Eur J Med Chem. 2014 Jul 23;82:164-71. doi: 10.1016/j.ejmech.2014.05.048. Epub 2014 May 22.

Reference Type: RESULT

PMID: 24904963 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31111370 (View on PubMed)

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.2017.03.016. Epub 2017 Apr 4.

Reference Type: RESULT

PMID: 28389404 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28951838 (View on PubMed)

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: 10.1007/s12031-022-01990-3. Epub 2022 Mar 10.

Reference Type: RESULT

PMID: 35274200 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/35274200/

efficacy of parkinson disease

https://link.springer.com/article/10.1007/s12035-020-01941-2

Crocin Reverses Depression-Like Behavior in Parkinson

Other Identifiers

9447

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Dr Saara Ahmad Muddasir Khan

Identifier Type: OTHER

Identifier Source: secondary_id

Dr Mahboob Alam

Identifier Type: REGISTRY

Identifier Source: secondary_id

F.2-81/2022-GENL/104/JPMC

Identifier Type: -

Identifier Source: org_study_id