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Treatment of a disease called Kampavata- disease with shaking and cognitive impairments, using a medicated ghee called Mahakalyanaka Ghrita in the form of Nasal drops and Internal medication to treat Cognitive and other impairments.

Phase 2
Not yet recruiting
Conditions
Parkinsons disease. Ayurveda Condition: KAMPAH/VEPATHUH,
Registration Number
CTRI/2023/06/054443
Lead Sponsor
Dr Shashikala V
Brief Summary

Parkinson’s disease is the second most common age related multisystemic progressive neurodegenerative disorder (1). Since long the main clinical focus in Parkinson’s disease has been on motor symptoms, however there is increasing recognition that the clinical spectrum of Parkinson’s disease is more extensive, including non motor symptoms such as variety of cognitive, neuropyschiatric, sleep, autonomic and sensory dysfuntions(2). Parkinson’s disease can be correlated to Kampavata in Ayurvedic classics and Clinical symptoms like Karapadatalakampa, Dehabhramana Dukhitha, Nidrabhanga, Matiksheena (3)has been mentioned.

It is estimated that the number of people with Parkinson’s disease worldwide is around 5 million persons and this number is expected to double within 20 years based on ageing of the population. The mean onset of Parkinson’s disease is at the age of 60 years and lifetime risk is 3% for men and 2% for women (4). In India, the prevalence rate of Parkinson’s disease per 1,00,000 population is 14 in North India, 27 in South and 16 in the East. (5)



In Contemporary Science, the goal of treatment for this disease is to alleviate symptoms that interfere with the patient’s activities of daily living and to prevent the complications. Non motor symptoms often carry a greater impact than motor symptoms in Parkinson’s disease . Although many non motor symptoms are resistant to Levodopa treatment, optimizing Dopaminergic therapies is viable avenue to improve control of some disabling non motor symptoms in Parkinson’s disease. (6)



In Ayurvedic Classics, treatment protocol for Kampavata can be considered as Samanya Vata Vyadhi Chikitsa. Among them Snehana Karma is adopted here as Pana and Nasya (7) to manage non motor features with Ghrita as it is Nitya Rasayana(8) Vata-Pitta Shamaka, Medhya, Smritikaraka (9)and also has property of crossing blood brain barrier (10) Mahakalyanaka Ghrita contains Kapikacchu as one of the main ingredient which is best Vatahara, Kshayahara, (11)Neuroprotective in action, and other ingredients having Antidepressant, Antianxiety, Antioxidant property. (12)



A very few studies have been carried out on non motor features of Parkinson’s disease. Hence, in this present study an effort is putforth to evaluate the efficacy of Mahakalyanaka Ghrita as Nasya and Shamana Sneha in the symptomatic management of non motor features of Parkinson’s disease along with improvement in quality of life.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
30
Inclusion Criteria
  • 1.Subjects between the age group of 40-70 years irrespective of gender.
  • 2.Subjects diagnosed with Kampavata/ Parkinson’s disease who fulfill any of the Non Motor Features mentioned in Diagnostic Criteria.
  • 3.Subjects with or without Standard Care of treatment for Parkinson’s disease.
  • 4.Subjects willing to give informed consent and participate in the study.
Exclusion Criteria
  • 1.Subjects diagnosed with other Neuro-Degenerative Diseases such as Alzheimer’s disease, Neurodegeneration with Brain Iron Accumulation and others which interfere with the course of treatment.
  • 2.Subjects diagnosed with Systemic Diseases such as Diabetic Autonomic Neuropathy, cardiac diseases and others which interfere with course of the treatment.
  • 3.Subjects diagnosed with Endocrinal diseases such as Hypoparathyroidism and Metabolic Disorders such as Dyslipidemia, Obesity and others which interfere with course of the treatment.
  • 4.Subjects diagnosed with Autoimmune diseases such as Multiple sclerosis, Systemic lupus erythematosus and others which interfere with the course of treatment.
  • 6.Subjects diagnosed with Brain Tumour and History of Head Injury.
  • 7.Subjects unfit for Nasya and Snehapana.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Significant improvement in non motor features of Parkinsons disease after completion of the trial.Pre test- Before commencement of treatment - 0th day. | Mid test- After Nasya - 8th day. | Post test- After Shamanaushadhi- 38th day
Secondary Outcome Measures
NameTimeMethod
Significant improvement in quality of life of subjects after completion of trial.Pre test- Before commencement of treatment - 0th day.

Trial Locations

Locations (1)

JSS Ayurveda Medical College and Hospital

🇮🇳

Mysore, KARNATAKA, India

JSS Ayurveda Medical College and Hospital
🇮🇳Mysore, KARNATAKA, India
Dr Shashikala V
Principal investigator
9902931875
drshashikala111@gmail.com

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