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CTRI Number  CTRI/2023/06/054443 [Registered on: 26/06/2023] Trial Registered Prospectively
Last Modified On: 22/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   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. 
Scientific Title of Study   Evaluation of Mahakalyanaka Ghrita as Nasya & Shamana Sneha in the management of Kampavata vis-a-vis Non motor features of Parkinsons Disease- A Single Arm Open Label Observational Clinical Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shashikala V 
Designation  PG Scholar 
Affiliation  Rajiv Gandhi University of Health Sciences  
Address  Department of PG Studies in Kayachikitsa OPD 1 JSS Ayurveda Medical College Lalithadripura road Alanahalli Mysuru

Mysore
KARNATAKA
570028
India 
Phone  9902931875  
Fax    
Email  drshashikala111@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Deepa C Patil  
Designation  Professor  
Affiliation  Rajiv Gandhi University of Health Sciences  
Address  Department of PG Studies in Kayachikitsa OPD no-1 JSS Ayurveda Medical College Lalithadripura road Alanahalli Mysuru

Mysore
KARNATAKA
570028
India 
Phone  9886485005  
Fax    
Email  deepsmysore@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shashikala V 
Designation  PG Scholar 
Affiliation  Rajiv Gandhi University of Health Sciences  
Address  Department of PG Studies in Kayachikitsa OPD no-1 JSS Ayurveda Medical College Lalithadripura road Alanahalli Mysuru

Mysore
KARNATAKA
570028
India 
Phone  9902931875  
Fax    
Email  drshashikala111@gmail.com  
 
Source of Monetary or Material Support  
JSS Ayurveda Medical College and Hospital Lalithadripura Road Alanahalli Mysuru- 570028 
 
Primary Sponsor  
Name  Dr Shashikala V 
Address  2nd Year PG Scholar Department of PG Studies in Kayachikitsa JSS Ayurveda Medical College and Hospital, Lalithadripura road, Alanahalli, Mysuru -570028  
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shashikala V   JSS Ayurveda Medical College and Hospital   Department of PG Studies in Kayachikitsa OPD no-1
Mysore
KARNATAKA 		 9902931875

drshashikala111@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Clearance Committee-Human , Jss Ayurveda Medical College and Hospital , Mysuru   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G20||Parkinsons disease. Ayurveda Condition: KAMPAH/VEPATHUH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Vangasena Samhitha - Vatavyadhi Nidana pg no 259, Procedure details: Mukha Abhyanga with Ksheerabala Taila followed by Pata Sweda. Mahakalyanaka Ghrita of 6 bindu i.e 3ml will be administered to each nostrils. Kavala with Ushna Jala & Dhoomapana with Haridra Dhoomavarti. Duration will be for 20-30 minutes.)
(1) Medicine Name: Mahakalyanaka Ghrita, Reference: Ashtanga Hridaya Uttarasthana 6/26-33, Route: Nasal, Dosage Form: Ghrita, Dose: 3(ml), Frequency: od, Duration: 7 Days
2Intervention ArmDrugClassical(1) Medicine Name: Mahakalyanaka Ghrita, Reference: Ashtanga Hridaya Uttarasthana 6/26-33, Route: Oral, Dosage Form: Ghrita, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Sukhoshna Jala), Additional Information: -
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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.
5.Subjects diagnosed with Secondary Parkinsonism, Parkinson plus syndromes, Psychiatric diseases such as Schizophrenia, Bipolar disorder 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 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
Significant improvement in quality of life of subjects after completion of trial.   Pre test- Before commencement of treatment - 0th day.
Mid test- After Nasya - 8th day.
Post test- After Shamanaushadhi- 38th day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/07/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="5" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.






 
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