| CTRI Number |
CTRI/2026/02/104114 [Registered on: 17/02/2026] Trial Registered Prospectively |
| Last Modified On: |
13/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Mahakalyanaka oil as nasal drop and oral medication along with regular treatment in Parkinsons Disease. |
|
Scientific Title of Study
|
AN OPEN LABEL RANDOMIZED CONTROLLED CLINICAL STUDY TO EVALUATE THE
EFFICACY OF MAHAKALYANAKA TAILA NASYA AND PANA AS AN ADJUVANT TO
STANDARD OF CARE IN KAMPAVATA vis à vis PARKINSONS DISEASE |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mandara Shetty V |
| Designation |
PG Scholar |
| Affiliation |
JSS Ayurveda Medical College and Hospital |
| Address |
JSS Ayurveda Medical College and Hospital
Department Of Kayachikitsa
41 E Lalithadripura Road
Mysore
KARNATAKA
570028
India |
| Phone |
8105341772 |
| Fax |
|
| Email |
mandarashetty5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepa C Patil |
| Designation |
Professor |
| Affiliation |
JSS Ayurveda Medical College and Hospital |
| Address |
JSS Ayurveda Medical College and Hospital
Department Of Kayachikitsa
41 E Lalithadripura Road
Mysore
KARNATAKA
570028
India |
| Phone |
9886485005 |
| Fax |
|
| Email |
deepsmysore@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepa C Patil |
| Designation |
Professor |
| Affiliation |
JSS Ayurveda Medical College and Hospital |
| Address |
JSS Ayurveda Medical College and Hospital
Department Of Kayachikitsa
41 E Lalithadripura Road
Mysore
KARNATAKA
570028
India |
| Phone |
9886485005 |
| Fax |
|
| Email |
deepsmysore@gmail.com |
|
|
Source of Monetary or Material Support
|
| Materials required for the treatment Mahakalyanaka Taila will be prepared from the GMP certified pharmacy . |
|
|
Primary Sponsor
|
| Name |
Dr Mandara Shetty V |
| Address |
JSS Ayurveda Medical College and Hospital
Department Of Kayachikitsa
41 E Lalithadripura Road
Mysuru
Karnataka
570028
India |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mandara Shetty V |
JSS Ayurveda Medical College and Hospital |
Department Of Kayachikitsa
OPD 1
41 E Lalithadripura Road
Mysore
KARNATAKA |
8105341772
mandarashetty5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Clearance Committee Human |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G20||Parkinsons disease. Ayurveda Condition: KAMPAH/VEPATHUH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: 8. Srikantha murthy K.R. Sushrutha samhitha. Volume II. Varanasi: Chaukambha orientalia; 2010, Chikitsasthana, chapter 31, verse 3, page no- 287, Procedure details: Purva Karma: Mukha Abhyanga with Ksheerabala Taila
followed by Mridu Sweda.
Pradhana Karma: Mahakalyanaka Taila of 6 bindu(29) (3ml)
will be administered to each nostril.
Paschat Karma: Kavala with Ushna Jala and Dhoomapana with Haridra Dhooma Varthi.
)
(1) Medicine Name: MAHAKALYANAKA TAILA, Reference: Bharata Bhaishajya Rathnakara , Route: Oral, Dosage Form: Taila, Dose: 24(ml), Frequency: bd, Duration: 30 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | STANDARD OF CARE | Standard of Care (Levodopa, Dopamine Agonists, Amantadine, Monoamine Oxidase type B Inhibitors (MAO-B), Anticholinergic drug, COMT Inhibitors) |
|
|
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Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects diagnosed with Kampavata (Parkinson’s disease) who fulfill mentioned diagnostic criteria.
2.Subjects between the age group of 50-70 years irrespective of gender, religion, occupation and their socio-economic status.
3.Subjects with Standard of Care in Parkinson’s Disease.
4.Subjects willing to give informed consent and participate in the study.
|
|
| ExclusionCriteria |
| Details |
1.Subjects diagnosed with Neuro-Degenerative Diseases such as Alzheimer’s disease and others which interfere with the course of treatment.
2.Subjects diagnosed with Movement disorder such as Huntington’s disease, Multiple system Atrophy and others which interfere with the course of treatment.
3.Subjects diagnosed with systemic diseases such as Diabetic Autonomic Neuropathy, Cardiac Diseases and others which interfere with the course of treatment.
4.Subjects diagnosed with Endocrinal diseases such as Hypoparathyroidism and Metabolic Disorders such as Dyslipidemia, Obesity and others which interfere with course of treatment.
5.Subjects diagnosed with Psychiatric diseases such as Schizophrenia, Bipolar disorder and others which interfere with the course of treatment.
6.Subjects diagnosed with Brain Tumor.
7.Subjects unfit for Nasya and Shamana Sneha.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Standard of Care and Mahakalyanaka taila Nasya and Pana as an adjuvant to Standard of Care in Kampavata vis-à-vis Parkinson’s Disease. |
After Nasya on 8th day
After Shamana Sneha on 38th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of Mahakalyanaka Taila Nasya & Pana as an adjuvant to Standard of Care in Kampavata vis a vis Parkinsons Disease.
To evaluate the effect of Standard of Care in Kampavata vis a vis Parkinsons Disease.
|
After Nasya on 8th day
After Shamana Sneha on 38th day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
02/03/2026 |
| 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="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 (PD) is the second most common age- related neurodegenerative disease, it is characterized by Tremors, Rigidity, Bradykinesia and Gait dysfunction with Postural instability, Speech difficulty, swallowing impairment, and series of non-motor features that include Autonomic disturbances, Sensory alterations, Mood disorders, Sleep dysfunction, Cognitive impairment, and Dementia. Parkinson’s disease can be taken parallel to Kampavata mentioned in Ayurvedic classics, where the lakshanas like Karapadatala Kampa, Dehabhramana Dukhitha, Nidrabhanga, Matiksheena are quoted.The incidence and prevalence of PD are rising. In the year 2021, the estimated global prevalence of PD was11.8 million people, increased from 6.1 million in 2016 and projected to reach 25.2 million by 2025. A similar trend has been observed in age-adjusted mortality from PD. Although aging of the world population accounts for much of the increase in absolute numbers, the age- adjusted incidence is also rising, for reasons that are not fully understood.The mean onset of Parkinson’s disease is at the age of 60 years, and lifetime risk is 3% for man and 2% for women. Treatment for PD is dopamine replacement therapy – Levodopa or Carbidopa, Other drugs like Amantadine, Monoamine Oxidase type B Inhibitors (MAO-B), Anticholinergic drug, Dopamine Agonists, COMT Inhibitors are used as the disease progresses. These medications may have complications on long term usage. Here the need of Ayurveda for better management of the condition and improving the quality of life. Acharya Vangasena stated the principles of the treatment for Kampavata as Abhyanga, Swedana, Nasya, Niruha, Anuvasana, Virechana and Shirobasti which is the main treatment for vata dosha and even increases the quality-of-life expectancy of patients suffering from Kampavata. In Kampavata increased Chala Guna of Vata produces Kampa whereas increased Manda Guna of Kapha produces Chestasanga. In Ayurvedic Classics, treatment protocol for Kampavata can be considered as Samanya Vata Vyadhi Chikitsa. Here Snehana Karma is adopted as Pana and Nasya in the form of Taila, which is having the properties of Vyavayi, Ushna, Guru and Snigdha Guna which is best for all Vata Vyadhi. Mahakalyanaka taila is specifically indicated in conditions such as Vepathu, Ardita, Dhanusthambha, Kubjata. It contains ingredients like Bhallataka (Semecarpus anacardium), Ashwagandha (Withania somnifera), which possess CNS Stimulant and Neuroprotective properties.Hence in this study, an attempt is made to study the combined effect of Mahakalyanaka Taila as Nasya and Pana in PD and in improving the quality of life.
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