A randomized open labelled comparative clinical study to evaluate the efficacy of oral administration of Maharasnadi Kashaya and Kapikacchu Choorna with Shuddha Bala Taila Matra Basti in the management of Kampavata with special reference to Parkinsons Disease.
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Significant decrease in symptoms of Parkinson’s Disease assessed based on MDS-UPDRS Scale.
Study Overview
Brief Summary
RESEARCH QUESTION
Whether oral administration of Maharasnadi kashaya along with Shuddha Bala taila
matra basti and Kapikachu choorna along with Shuddha Bala Taila Matra Basti is
effective in the management of Kampavata with special reference to Parkinson’s
Disease?
HYPOTHESIS
Null Hypothesis (H 0 ) = There is no significant difference between the two groups in
the clinical efficacy of Maharasnadi kashaya orally along with Shuddha Bala taila
matra basti and Kapikachu choorna orally along with Shuddha Bala taila matra basti
in the management of Kampavata with special reference to Parkinson’s Disease.
Alternative Hypothesis (H 1 ) = The clinical efficacy of Maharasnadi kashaya orally
along with Shuddha Bala taila matra basti is better than Kapikachu choorna orally
along with Shuddha Bala taila matra basti in Kampavata with special reference to
Parkinson’s Disease.
Alternative Hypothesis (H 2 ) : The clinical efficacy of Kapikachu choorna orally along
with Shuddha Bala Taila Matra Basti is better than Maharasnadi kashaya orally along
with Shuddha Bala taila matra basti in Kampavata with special reference to
Parkinson’s Disease.
6.4 AIM AND OBJECTIVES OF THE STUDY:
AIM: To clinically evaluate and compare the efficacy of Maharasnadi kashaya with
that of Kapikachu choorna along with Shuddha Bala taila matra basti in the
management of Kampavata with special reference to Parkinson’s Disease.
OBJECTIVES OF THE STUDY:
Primary objective:
â— To clinically evaluate the efficacy of Maharasnadi kashaya with Shuddha Bala taila
matra basti in the management of Kampavata with Movement Disorder Society-
unified Parkinson’s Disease Rating Scale (MDS-UPDRS) in the clinical setting of the
institution.
â— To clinically evaluate the efficacy of Kapikachu choorna with Shuddha Bala taila matra
basti in the management of Kampavata with MDS-UPDRS scale in the clinical setting
of the institution.
â— To clinically compare and evaluate the efficacy of Maharasnadi kashaya and
Shuddha Bala taila matra basti with Kapikachu choorna and Shuddha Bala taila matra
basti in management of Kampavata with MDS-UPDRS scale in the clinical setting of
the institution.
Secondary objective:
â— To undertake the detailed literary review of Kampavata with special reference to
Parkinson’s Disease.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 40.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Subjects presenting with the lakshanas of Kampavata like karapaadatale kampa(tremors), deha bhramana (whirling sensation), nidrabhanga(sleeplessness) and kshinamati (dementia).
- •Subjects presenting the clinical features of PD like tremors, rigidity, bradykinesia.
- •Subjects who have been freshly diagnosed with Idiopathic PD or less than 5 year history and those who are not on any medications for Parkinson’s disease.
- •Subjects irrespective of gender in between the age group 40 to 65 years.
- •Subjects who are indicated and fit for Matra basti.
- •Subjects willing to participate with written informed consent, which is conveyed in the language, which the subject can understand.
Exclusion Criteria
- •Subjects with other varieties of Tremors like essential tremors, senile tremors.
- •Subjects who are on any medications for Parkinson’s disease.
- •Subjects diagnosed with uncontrolled systemic diseases like HTN and DM.
- •Subjects with history of Major head injury.
Outcomes
Primary Outcomes
Significant decrease in symptoms of Parkinson’s Disease assessed based on MDS-UPDRS Scale.
Time Frame: Before intervention- 0th day | After intervention- 30th day | Follow up- 45th day
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Prekshna Gabriella Paul
Sri Sri College of Ayurvedic Science and research