Parkinson DiseaseSAFCHEMRxParNCT05696665
Role of Saffron and Chamomile in the Management of Parkinson's Disease
A study testing conventional therapy, Saffron and Chamomile and Crocin and Apigenin in people with Parkinson Disease and Neurodegenerative Diseases, run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Neurodegenerative Diseases
- What is being tested?
- conventional therapy, Saffron and Chamomile and Crocin and Apigenin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Jul 2022to Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- • Patients with atypical Parkinsonism will be excluded.
- Patients with uncontrolled comorbidities will also be excluded.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Jinnah Postgraduate Medical Centre (JPMC),
Karachi, Sindh, 00000
Fizzah Ali, MPhill, 03333235882, fizzah.saqib@gmail.com
Saara Mudassir, PhD, 0333 3448258, saara.muddasir@aku.edu
About this study
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
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
Read the 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
- 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
- Being tested
- conventional therapy, Saffron and Chamomile, Crocin and Apigenin
- Keywords
- saffron, Chamomile, Parkinson, Apigenin, Crocin, Neurodegenerative disorder
- Medical subject headings
- Parkinson Disease, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional therapyOther
Patients will be kept on conventional therapy and no added drugs will be given
Saffron and ChamomileDrug
Patients will be given saffron and chamomile in capsule formulation twice daily
Crocin and ApigeninDrug
Active ingredients of saffron(Crocin) and Chamomile(Apigenin) will be given in capsule formultaion once daily
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | conventional therapy only Receives: Other: conventional therapy |
| Group B | Experimental | conventional therapy +500 mg chamomile 15 mg saffron twice daily Receives: Drug: Saffron and Chamomile |
| Group C | Experimental | conventional therapy +500mgApigenin +30mg Crocin once daily Receives: Drug: Crocin and Apigenin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 4 months
Level of antioxidant:Superoxide Dismutase (SOD)
levels of Superoxide Dismutase (SOD) will be measured on day 0 and last day of trial
Measured: 4 months
Secondary outcomes (1)
Incidence of treatment -Emergent Adverse Events(Safety and Evaluation)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start5 Jul 2022
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- GROUP A Conventional drugs only 40 GROUP B:Conventional drugs +1000 mg chamomile 30 mg saffron in a capsule form GROUP C:GROUP C Conventional drugs +500mgApigenin +30mg Crocin 40
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinnah Postgraduate Medical Centre
- Sponsor type
- Other government
- Collaborators
- Aga Khan University Hospital, Pakistan, Liaquat National Hospital & Medical College
- Responsible party
- Principal investigator, Fizzah Ali, Jinnah Postgraduate Medical Centre
- Investigators
- Fizzah Ali, MBBS,MPhil, Principal investigator, Liaquat National hospital and Medical college
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05696665
- Sponsor's protocol ID
- F.2-81/2022-GENL/104/JPMC
- Other IDs
- 9447, Dr Saara Ahmad Muddasir Khan, Dr Mahboob Alam
- Acronym
- SAFCHEMRxPar
- Status last verified
- Jan 2023
- First submitted
- 20 Dec 2022
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD and results along with publications will be shared
Publications
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.
PubMed 27706421Haeri 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.
PubMed 30159851Inoue 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.
PubMed 29147836Inoue 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.
PubMed 34224829De 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.
PubMed 24904963Ghasemi 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.
PubMed 31111370Anusha 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.
PubMed 28389404Siddique 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.
PubMed 28951838Mohammadzadeh 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.
PubMed 35274200
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05696665
- Acronym / sponsor ID
- SAFCHEMRxPar / F.2-81/2022-GENL/104/JPMC
- Conditions
- Parkinson Disease, Neurodegenerative Diseases
- Keywords
- saffron, Chamomile, Parkinson, Apigenin, Crocin, Neurodegenerative disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Jinnah Postgraduate Medical CentreOther government
- Collaborators
- Aga Khan University Hospital, Pakistan, Liaquat National Hospital & Medical College
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- GROUP A Conventional drugs only 40 GROUP B:Conventional drugs +1000 mg chamomile 30 mg saffron in a capsule form GROUP C:GROUP C Conventional drugs +500mgApigenin +30mg Crocin 40
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: conventional therapyconventional therapy only |
| Group B | Experimental | Drug: Saffron and Chamomileconventional therapy +500 mg chamomile 15 mg saffron twice daily |
| Group C | Experimental | Drug: Crocin and Apigeninconventional therapy +500mgApigenin +30mg Crocin once daily |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- • All diagnosed patients aged 40-years and above of either sex will be included
Key exclusion criteria (2 listed)
- • Patients with atypical Parkinsonism will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional therapyPatients will be kept on conventional therapy and no added drugs will be given | Other | Group A |
| Saffron and ChamomilePatients will be given saffron and chamomile in capsule formulation twice daily | Drug | Group B |
| Crocin and ApigeninActive ingredients of saffron(Crocin) and Chamomile(Apigenin) will be given in capsule formultaion once daily | Drug | Group C |
Primary outcome
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
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
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
1 secondary outcome
Incidence of treatment -Emergent Adverse Events(Safety and Evaluation)
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Results publication: PubMed 27706421Rajaei 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.
- Results publication: PubMed 30159851Haeri 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.
- Results publication: PubMed 29147836Inoue 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.
- Results publication: PubMed 34224829Inoue 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.
- Results publication: PubMed 24904963De 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.
- Results publication: PubMed 31111370Ghasemi 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.
- Results publication: PubMed 28389404Anusha 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.
- Results publication: PubMed 28951838Siddique 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.
- Results publication: PubMed 35274200Mohammadzadeh 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.
- efficacy of parkinson diseaseLink provided by the sponsor.
- Crocin Reverses Depression-Like Behavior in ParkinsonLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD and results along with publications will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fizzah Ali, MBBS,MPhil principal investigator
Liaquat National hospital and Medical college
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional therapy, Saffron and Chamomile and Crocin and Apigenin in people with Parkinson Disease and Neurodegenerative Diseases, run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fizzah Ali, MBBS, MPhil (+923333235882, fizzah.saqib@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (time frame: 4months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05696665, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.