Ignite Creation Date:
2024-05-06 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05696665
Status:
RECRUITING
Last Update Posted:
2023-01-25
First Post:
2022-12-20
Brief Title:
Role of Saffron and Chamomile in the Management of Parkinsons Disease
Sponsor:
Jinnah Postgraduate Medical Centre
Organization:
Jinnah Postgraduate Medical Centre
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAFCHEMRxPar
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 Parkinsons 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 Parkinsons disease This combination may change psychometric measures MDS-Unified Parkinsons Disease Rating Scale biomarkers including Alpha-synuclein and oxidative stress-related to Parkinsons disease This combination along with conventional therapy might be beneficial in managing patients with Parkinsons disease
Detailed Description:
Parkinsons diseasePD 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 bulbs 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 Saffrons taste unique color r Saffrons 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 neuroprotectiveanxiolytic 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
Saffron is a perennial plant that grows to a height of 10 to 30 cm Numerous leaves branch out from the bulbs 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 Saffrons taste unique color r Saffrons 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 neuroprotectiveanxiolytic 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Dr Mahboob Alam | REGISTRY | Karachi University | None |
| 9447 | OTHER_GRANT | None | None |
| Dr Saara Ahmad Muddasir Khan | OTHER | None | None |