| CTRI Number |
CTRI/2026/02/104424 [Registered on: 20/02/2026] Trial Registered Prospectively |
| Last Modified On: |
20/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Study Comparing Two Ayurvedic Oral Medicines Along with Medicated Nasal Therapy in Parkinsons Disease |
|
Scientific Title of Study
|
A Randomized open-label clinical study on the efficacy of Vishwadi Guggulu with Ksheerbala 101 Avartana Taila Pratimarsha Nasya with special reference to Parkinsons disease and its comparison with the efficacy of Kapikacchu Choorna with Ksheerbala 101 Avartana Taila Pratimarsha Nasya. |
| 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 Shruthi S |
| Designation |
PG Scholor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Room No 5
Department of Kayachikitsa
Sri Sri College of Ayurvedic Science and Research
Kanakapura Road, Udayapura Post
Bengaluru – 560082
Karnataka, India
Bangalore
KARNATAKA
560082
India |
| Phone |
9663226022 |
| Fax |
|
| Email |
shruthishankar888@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gayathri R |
| Designation |
Associate Proffesor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Room No 5
Department of Kayachikitsa
Sri Sri College of Ayurvedic Science and Research
Kanakapura Road, Udayapura Post
Bengaluru – 560082
Karnataka, India
Bangalore
KARNATAKA
560082
India |
| Phone |
07598175115 |
| Fax |
|
| Email |
drgayathrig3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayathri R |
| Designation |
Associate Proffesor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Room No. 5
Department of Kayachikitsa
Sri Sri College of Ayurvedic Science and Research
Kanakapura Road, Udayapura Post
Bengaluru – 560082
Karnataka, India
Bangalore
KARNATAKA
560082
India |
| Phone |
07598175115 |
| Fax |
|
| Email |
drgayathrig3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurvedic Science and Research
Kanakapura Road Udayapura Post
Bengaluru – 560082
Karnataka, India
|
|
|
Primary Sponsor
|
| Name |
Dr Shruthi S |
| Address |
Sri Sri College of Ayurvedic Science and Research
Kanakapura Road, Udayapura Post
Bengaluru – 560082
Karnataka 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 Shruthi S |
Sri Sri College of Ayurvedic Science and Research Centre |
Room No. 5
Department of Kayachikitsa
Sri Sri College of Ayurvedic Science and Research
Kanakapura Road Udayapura Post
Bengaluru 560082
Karnataka India
Bangalore
KARNATAKA |
9663226022
shruthishankar888@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SRI INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
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 | - | pratimarSaH, प्रतिमर्श | (Procedure Reference: A Textbook of Panchakarma by Dr Lohith BA, Procedure details: Poorvakarma-
Subjects will be asked to lie down on the table on his back with his head end
lowered. Then bend the head slightly backwards and hold the nostrils with left
thumb.
Pradhana karma
The subject is advised to instill 5drops of Ksheerabala 101 Avartana Taila into the
right nostril while keeping the left nostril closed, followed by 5 drops into the left
nostril while keeping the right nostril closed and instructed to sniff gently.
Paschat
karma
-Thesubjectisadvisedtogentlymassage the forehead,face,andneck,
followed by lying down ina supine positionfor 5– 10 minutes.
Instructions will be given to the subject to spit out anytaila that drips
into the throat, without forceful expectoration)
(1) Medicine Name: Ksheerabala 101 Avartana taila, Reference: Astanga Hridaya chikitsa sthana 22nd chapter , Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 5(drops), Frequency: od, Duration: 30 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vishwadi Guggulu , Reference: Brihannighantu Ratnakara , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2(NA), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Sukoshna jala ), Additional Information: 2 tablets three times a day with warm water | | 3 | Comparator Arm | Procedure | - | pratimarSaH, प्रतिमर्श | (Procedure Reference: A Text book of panchakarma by Dr.Lohith BA , Procedure details: Procedure details:
1) Poorvakarma- Subjects will be asked to lie down on the table on his back with his head end lowered. Then bend the head slightly backwards & hold the nostrils with left thumb.
2)Pradhana karma -The subject is advised to instill 5drops of Ksheerabala 101 Avartana Taila into the right nostril while keeping the left nostril closed, followed by 5 drops into the left nostril while keeping the right nostril closed & instructed to sniff gently.
3) Paschat karma -The subject is advised to gently massage the forehead,face,andneck, followed by lying down in a supine position for 5– 10 minutes. Instructions will be given to the subject to spit out any taila that drips into the throat, without forceful expectoration)
(1) Medicine Name: Ksheerabala 101 Avartna Taila, Reference: Asatanga Hridaya Chikitsa Sthana 22nd Chapter, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 5(drops), Frequency: od, Duration: 30 Days)
(1) Medicine Name: Ksheerabala 101 Avartana taila , Reference: Astanaga Hridaya Chikitsa Sthana 42nd Chapter, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 5(drops), Frequency: od, Duration: 30 Days | | 4 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kapikacchu Choorna, Reference: Bhavapraskasha Nighantu Hartitakyadi varga, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -sukoshna jala), Additional Information: -with warm water |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects in the 40 to 70 age range regardless of gender
2.Subjects who exhibit two or more classical clinical symptoms of Kampavata like Karapada tale kampa, Deha bhrama , Dukha, Nidrabhanga , and Mati ksheena
3.Subjects presenting with two or more clinical features of Parkinsons Disease like tremors, bradykinesia ,rigidity, postural instability, sleep disturbances ,cognitive impairment
4.Subjects who have been freshly diagnosed with Idiopathic PD
5.Subjects willing to participate with written informed consent in the language they can understand |
|
| ExclusionCriteria |
| Details |
1.Subjects with other varieties of Tremors like essential tremors, senile tremors.
2.Subjects who are currently receiving any concurrent medication for Parkinsons disease.
3.Subjects diagnosed with uncontrolled metabolic disorders like Diabetes mellitus, Hypertension and Thyroid disorders.
4.Subjects with history of Traumatic Head Injury.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in symptoms of Parkinson’ s Disease based on MDS-UPDRS Scale |
Group A-Vishwadi guggulu with Ksheerabala 101 Avartana talia pratimarsha nasya (Trail group )
Group B- Kapikacchu choorna with Ksheerabala 101 Avartana talia pratimarsha nasya (Comparitive group)
Trail period-30 days
Assesment will be done on 0th day baseline day ,31st day and 45th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Generation of in- depth analyzed data on the different aspects of the disease.
2. Improvement in Quality of life
3.Generation of data on possible unexpected drug reaction |
Group A-Vishwadi guggulu with Ksheerabala 101 Avartana talia pratimarsha nasya (Trail group )
Group B- Kapikacchu choorna with Ksheerabala 101 Avartana talia pratimarsha nasya (Comparitive group)
Trail period-30 days
Assesment will be done on 0th day baseline day ,31st day & 45th 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 3 |
|
Date of First Enrollment (India)
|
05/03/2026 |
| 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="1"
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 disease is a progressive neurodegenerative disorder that mainly affects elderly people and causes tremors rigidity slow movements and gait problems. It is the second most common neurodegenerative disease worldwide and its global burden has increased significantly over the past decades with further rise expected in the coming years. In India it represents a major proportion of neurodegenerative disorders. Current treatments such as Levodopa and dopamine agonists provide symptomatic relief but are associated with behavioral and non behavioral side effects.
In Ayurveda Parkinson disease closely resembles Kampavata a disorder related to Vata Dosha. Symptoms described in classical texts include tremors in hands and feet giddiness discomfort disturbed sleep and cognitive decline which greatly affect quality of life. Although Ayurveda offers potential therapies for Vata disorders there is limited modern clinical evidence supporting its role in managing Kampavata. Therefore scientific evaluation is needed.
Vishwadi Guggulu mentioned in classical texts is considered beneficial for managing tremors and is selected for evaluation in this study. Kapikacchu known for its nourishing and Vata balancing properties and as a natural source of L dopa is chosen as a comparative drug. In addition Pratimarsha Nasya using Ksheerabala 101 Avartana Taila is administered in both groups based on the Ayurvedic principle that the nose acts as a gateway to the brain helping to balance Vata in the central nervous system |