A study to establish the standard ayurvedic treatment protocol for Parkinsons disease(Kampavata).

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/08/004894
• Date of registration: 20-08-2014
• Prospective Registration: Yes
• Primary sponsor: IPGT And RA Gujarat Ayurved University Jamnagar
• Public title: A study to establish the standard ayurvedic treatment protocol for Parkinsons disease(Kampavata).
• Scientific title: A Study To Establish The Standard Treatment Protocol For Parkinsons Disease(Kampavata)
• Date of first enrolment: 10-10-2014
• Target sample size: 10
• Recruitment status: Not Yet Recruiting
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=8510
• Study type: Interventional
• Study design: Single Arm Trial; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label
• Phase: Phase 2

Countries of recruitment

India

Contacts

• Name: Prof MS BAGHEL
• Affiliation: IPGT And RA Gujarat Ayurved University Jamnagar

• Name: Prof MS BAGHEL
• Affiliation: IPGT And RA Gujarat Ayurved University Jamnagar

Key inclusion & exclusion criteria

Inclusion criteria: 1 Patients fulfilling the diagnostic criteria.

2 Patients who are willing and able to participate in the study.


Exclusion criteria: 1 Repeated strokes with stepwise progression

2 Repeated head injury

3 Definite encephalitis

4 More than one affected relative.

5 Presence of cerebral tumour

6 Patients with uncontrolled Diabetes Mellitus and having a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in last 6 months



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Patients suffering from Parkinsons disease

Intervention(s)

Intervention1: The following standard treatment protocol has been developed for Parkinsons Disease-Dipana Pachana with Sunthi siddha jal 100ml Prataha abhakta kaal along with Koshtha Shuddhi with Eranda Bhristha Haritaki 6 gms at night with koshnajal for 3 days,Snehapana with Mashadi Taila 40 ml once for 7 days,Sarvanga Abhyanga Mashadi Taila And Swedana along with Marsh Nasya 6 bindu with Mashadi Taila once for 8 days,Tritiya Baladi Yapana Basti Upakrama for 21 days Dose 9 Prasrut 720 ml to 12 prasrut 960 ml and Aushadhi Sevana Oral Medicine for 1 month which includes Ashwagandha choorna 2 gms Kapikacchu choorna 4 gms Sunthi choorna 1 gm BD for 1 month along with milk.: Duration-69 days.
Follow up-1 month after the completion of the treatment

Intervention2: This study is single arm study
which includes 10 patients
suffering from Parkinsons
disease.taila,Tritiyabaladi yapana basti: The following standard
treatment protocol has been
developed for Parkinsons
Disease Dipana Pachana with
Sunthi siddha jal 100ml Prataha
abhakta kaal along with
Koshtha Shuddhi with Eranda
Bhristha Haritaki 6 gms at night
with koshnajal for 3
days,Snehapana with Mashadi
Taila 40 ml once for 7 days
,Sarvanga Abhyanga Mashadi
Taila And Swedana along with
Marsh Nasya 6 bindu with
Mashadi Taila once for 8 days
,Tritiya Baladi Yapana Basti
Upakrama for 21 days Dose 9
Prasrut 720 ml to 12 prasrut 960
ml and Aushadhi Sevana Oral
Medicine for 1 month which
includes Ashwagandha choorna 2 gms Kapikacchu choorna 4
gms Sunthi choorna 1 gm BD
for 1 month along with milk
Control Intervention1: Nil: Nil

Primary Outcome(s)

The changes in the subjective and objective parameters before and after the treatment shall be considered for assessment of the safety and efficacy the drug.Timepoint: 69 days

Secondary Outcome(s)

Improvement will be assessed on the basis of

relief found in cardinal symptoms of

diseaseProgress in the signs and symptoms

based on the standard pattern will be applied

before and after treatment.Timepoint: 69 days

Secondary ID(s)

NIL

Source(s) of Monetary Support

Institute for Post Graduate Teaching and Research in Ayurveda jamnagar 361008

Ethics review

Status: Approved
Approval date: 10/09/2013
Contact:

Institutional ethics committee Institute for Post Graduate Training and Research in Ayurved Gujarat Ayurved University Jamnagar 361008