Role of Saffron and Chamomile in the Management of Parkinson's Disease
SAFCHEMRxPar
4 other identifiers
interventional
120
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable parkinson-disease
Started Jul 2022
Shorter than P25 for not_applicable parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 5, 2022
CompletedFirst Submitted
Initial submission to the registry
December 20, 2022
CompletedFirst Posted
Study publicly available on registry
January 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedJanuary 25, 2023
January 1, 2023
12 months
December 20, 2022
January 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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 Outcomes (1)
Incidence of treatment -Emergent Adverse Events(Safety and Evaluation)
4 months
Study Arms (3)
Group A
ACTIVE COMPARATORconventional therapy only
Group B
EXPERIMENTALconventional therapy +500 mg chamomile 15 mg saffron twice daily
Group C
EXPERIMENTALconventional therapy +500mgApigenin +30mg Crocin once daily
Interventions
Patients will be kept on conventional therapy and no added drugs will be given
Patients will be given saffron and chamomile in capsule formulation twice daily
Active ingredients of saffron(Crocin) and Chamomile(Apigenin) will be given in capsule formultaion once daily
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients with atypical Parkinsonism will be excluded.
- Patients with uncontrolled comorbidities will also be excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jinnah Postgraduate Medical Centre (JPMC),
Karachi, Sindh, 00000, Pakistan
Related Publications (9)
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.
PMID: 27706421RESULTHaeri 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.
PMID: 30159851RESULTInoue 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.
PMID: 29147836RESULTInoue 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.
PMID: 34224829RESULTDe 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.
PMID: 24904963RESULTGhasemi 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.
PMID: 31111370RESULTAnusha 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.
PMID: 28389404RESULTSiddique 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.
PMID: 28951838RESULTMohammadzadeh 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.
PMID: 35274200RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fizzah Ali, MBBS,MPhil
Liaquat National hospital and Medical college
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
December 20, 2022
First Posted
January 25, 2023
Study Start
July 5, 2022
Primary Completion
July 1, 2023
Study Completion
July 1, 2023
Last Updated
January 25, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- 6 months after publication of the primary outcomes
- Access Criteria
- Data and study material will be shared6months after the completion of study and after publicationsof primary outcomes
All IPD and results along with publications will be shared