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

January 23, 2023 updated by: Fizzah Ali, Jinnah Postgraduate Medical Centre

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 00000
        • Recruiting
        • Jinnah Postgraduate Medical Centre (JPMC),
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fizzah Ali
        • Sub-Investigator:
          • Saara /mudassir, PhD
        • Sub-Investigator:
          • Mehboob Alam, PhD
        • Sub-Investigator:
          • Junaid Ahmed, FCPS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale
Time Frame: 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
4months
Levels of Alpha-synuclein and Human Neurofilament Light
Time Frame: 4 months
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)
Time Frame: 4 months
levels of Superoxide Dismutase (SOD) will be measured on day 0 and last day of trial
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of treatment -Emergent Adverse Events(Safety and Evaluation)
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jinnah Postgraduate Medical Centre

Collaborators

Aga Khan University Hospital, Pakistan
Liaquat National Hospital & Medical College

Investigators

  • Principal Investigator: Fizzah Ali, MBBS,MPhil, Liaquat National Hospital and Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 5, 2022

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

July 1, 2023

Study Registration Dates

First Submitted

December 20, 2022

First Submitted That Met QC Criteria

January 23, 2023

First Posted (Estimate)

January 24, 2023

Study Record Updates

Last Update Posted (Estimate)

January 24, 2023

Last Update Submitted That Met QC Criteria

January 23, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F.2-81/2022-GENL/104/JPMC
  • 9447 (Other Grant/Funding Number: HEC)
  • Dr Saara Ahmad Muddasir Khan (Other Identifier: Aga Khan University)
  • Dr Mahboob Alam (Registry Identifier: Karachi University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All IPD and results along with publications will be shared

IPD Sharing Time Frame

6 months after publication of the primary outcomes

IPD Sharing Access Criteria

Data and study material will be shared6months after the completion of study and after publicationsof primary outcomes

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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