Ayurvedic Treatment in the Rehabilitation of Ischemic Stroke Patients in India: A Randomized Controlled Trial (RESTORE)

 

No clue what Ayurvedic treatment is.  You'll have to ask your doctor.

Ayurvedic Treatment in the Rehabilitation of Ischemic Stroke Patients in India: A Randomized Controlled Trial (RESTORE)

P.N. Sylaja https://orcid.org/0000-0003-4896-8275 sylajapn@sctimst.ac.in, Vivek Nambiar, […], and Jeyaraj Durai Pandian https://orcid.org/0000-0003-0028-1968+13View all authors and affiliations

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https://doi.org/10.1177/17474930251349727

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Abstract

Background:

The effect of Ayurvedic Rehabilitation therapy (ART) in improving the sensorimotor recovery of patients with ischemic stroke is unclear irrespective of the fact that ayurveda is a commonly practiced alternate system of medicine in India and south Asia. The trial hypothesised that ayurvedic treatment is superior to physiotherapy in recovery of ischemic stroke patients.

Methods:

We performed investigator-initiated, multi-centre prospective, parallel arm randomized, controlled trial (RCT) with blinded outcome assessment across four comprehensive stroke centres in India. Participants were randomly assigned in a 1:1 ratio to the ART arm (intervention group) or on to the conventional physiotherapy (C PT) arm (control group). The primary outcome was sensory motor recovery of upper extremity assessed using Fugl Meyer Assessment -upper extremity (FMA-UE) and secondary outcome, a composite of functional disability, activities of daily living, postural balance and quality of life at one month and three-month follow-up. The safety outcomes were serious adverse events during the study duration.

Results:

Of 403 participants screened, 140 patients were enrolled, 70 in intervention (ART) and 70 in control (CPT) group. At three months, compared to ayurveda group, the sensory motor impairment (FMA-UE) score was significantly better in the physiotherapy group (71.97+ 23.88 Vs 81.97 +24.57, p=0.023) but after adjusting for age, stroke severity, baseline FMA-UE scale and risk factors, the group differences were not significant (p= 0.057). None of the secondary outcomes were significantly better in ayurveda group. During the trial, no major serious adverse events were reported.

Conclusion:

This pragmatic first-ever RCT of Ayurveda in stroke looked into benefit of ayurveda treatment in first ever stroke survivors. The current intervention protocol of ART was not superior to CPT in improving the sensorimotor recovery of patients with ischemic stroke. This is the first RCT of its kind.

Funding:

Funded by Indian Stroke Clinical Trial (INSTRuCT) Network, Indian Council of Medical Research,registered in Clinical Trial Registry- India (CTRI/2018/04/013379)

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Ayurvedic Treatment in the Rehabilitation of Ischemic Stroke Patients in India: A Randomized Controlled Trial Study Protocol

No clue what Ayurvedic treatment is.  You'll have to ask your doctor.

 

Ayurvedic Treatment in the Rehabilitation of Ischemic Stroke Patients in India: A Randomized Controlled Trial Study Protocol

Subject Area: Cardiovascular System , Neurology and Neuroscience

Padmavathy Narayana Sylaja;

Jaya Pankajakshi Raghavan Nair;

Mahesh Pundlik Kate;

Aneesh Dhasan;

Vivek Nambiar;

Sunil Narayan;

Vishnu Renjith;

Deepti Arora;

Shweta Jain Verma;

Meenakshi Sharma;

Rupinder Dhaliwal;

Himani Khatter;

PS Sarma;

Jeyaraj Durai Pandian;

RESTORE Collaborators

Cerebrovasc Dis 1–7.

https://doi.org/10.1159/000530546

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Abstract

In patients with ischemic stroke, motor and sensory impairments are common and are associated with functional disability. Conventional physiotherapy (CP) is the primary modality of rehabilitation for post-stroke sensorimotor dysfunction. Ayurveda is a commonly practiced alternative system of medicine that offers unique rehabilitative measures for post-stroke recovery. We hypothesize that Ayurvedic rehabilitative treatment (ART) is superior to similar duration CP in improving the sensorimotor recovery of patients with ischemic stroke at 90 days after enrollment. AyuRvedic TrEatment in the Rehabilitation of Ischemic STrOke Patients in India: A Randomized controllEd trial (RESTORE) is an investigator-initiated, multicenter, prospective, randomized, controlled, parallel-arm, blinded outcome assessment trial being conducted under the Indian Stroke Clinical Trial (INSTRuCT) Network across the four comprehensive stroke centers in India. Consecutive hemodynamically stable adult patients with their first acute ischemic stroke between 1 and 3 months from stroke onset are being randomized (1:1) into two treatment groups to receive either 1 month of ART or 1 month of CP. The primary outcome measure is the Fugl Meyer Assessment-upper extremity for physical performance at 90 days. The secondary outcomes are the modified Rankin Scale, Barthel Index, Berg Balance, and SF-36 at 90 days. The safety outcomes include a composite of irreversible morbidity and mortality. A sample size of 140 (70 in each group) patients with ischemic stroke will allow us to detect a minimal clinical important difference of 9.4 (standard deviation) with superiority margin of 5, an attrition rate of 10%, alpha of 5%, and power of 80%. This randomized trial will systematically assess the efficacy and safety of traditional ART compared to CP. The trial has been registered in the Clinical Trial Registry India (CTRI/2018/04/013379).

Ayurvedic Treatment in the Rehabilitation of Ischemic Stroke Patients in India: A Randomized Controlled Trial (RESTORE) study protocol

No clue what Ayurvedic treatment is.  You'll have to ask your doctor.

Ayurvedic Treatment in the Rehabilitation of Ischemic Stroke Patients in India: A Randomized Controlled Trial (RESTORE) study protocol

 

https://doi.org/10.1159/000530546

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Abstract

Background: 

In patients with ischemic stroke, motor and sensory impairments are common and are associated with functional disability. Conventional physiotherapy (CP) is the primary modality of rehabilitation for post-stroke sensorimotor dysfunction. Ayurveda is a commonly practiced alternative system of medicine that offers unique rehabilitative measures for post-stroke recovery. 

Hypothesis: 

We hypothesize that Ayurvedic rehabilitative treatment (ART) is superior to similar duration CP in improving the sensorimotor recovery of patients with ischemic stroke at 90 days after enrollment. 

Design: 

AyuRvedic TrEatment in the Rehabilitation of Ischemic STrOke Patients in India: A Randomized controllEd trial (RESTORE) is an investigator-initiated, multi-center, prospective, randomized, controlled, parallel-arm, blinded outcome assessment trial being conducted under the Indian Stroke Clinical Trial (INSTRuCT) Network across the four comprehensive stroke centers in India. Consecutive hemodynamically stable adult patients with their first acute ischemic stroke, between 1 to 3 months from stroke onset are being randomized (1:1) into two treatment groups to receive either 1 month of ART or 1 month of CP. 

Outcome: 

The primary outcome measure is the Fugl Meyer Assessment-Upper extremity for physical performance at 90 days. The secondary outcomes are the modified Rankin Scale, Barthel Index, Berg Balance and SF-36 at 90 days. The safety outcomes include a composite of irreversible morbidity and mortality. Sample Size: A sample size of 140 (70 in each group) patients with ischemic stroke will allow us to detect a minimal clinical important difference of 9.4 (standard deviation) with superiority margin of 5, an attrition rate of 10%, alpha of 5% and power of 80%. 

Summary: 

This randomised trial will systematically assess the efficacy and safety of traditional ART compared to CP. Trial registration: This trial is registered with Clinical Trial Registry - India; CTRI/2018/04/013379. 

S. Karger AG, Basel

Sylaja P.N. · PR J. · Kate M.P. · Dhasan A. · Nambiar V. · Narayan S. · Renjith V. · Arora D. · Verma S.J. · Sharma M. · RS D. · Khatter H. · Sarma P.S. · Pandian J.D.

Clinical evaluation of the Dr. Brain syrup in the treatment of anxiety, depression, and dementia: randomized, placebo controlled, single blinded clinical study

Wow, how soon will this get rolled out to the rest of the world? Nobel prize work here if true. I think this really proves the strength of the placebo effect of saying that the title of the concoction is Dr. Brain. 

Clinical evaluation of the Dr. Brain syrup in the treatment of anxiety, depression, and dementia: randomized, placebo controlled, single blinded clinical study

Hardik R. Patel, Kalapi Patel, Mansi Patel, S. N. Gupta, Janmejay Patel, Payal Patel, Apurva Patel

Abstract

Background: Epidemiological studies of Indian population show that dementia, anxiety, and depression are largely a major hidden problem in India. Ayurveda claims several plants are beneficial in cognitive disorders. The prime objective of study was to clinically evaluate polyherbal formulation (Dr. Brain syrup) and compare it with the Placebo. It was randomized, placebo controlled, single blinded clinical study, approved by Institutional Human Ethics Committee.
Methods: 60 outpatients from P. D. Patel Ayurveda Hospital (8-70 years) ready to sign Informed consent form were included in study. All these patients were given either Placebo syrup or Dr. Brain syrup at similar dose of 10 ml twice a day for 6 weeks. They were evaluated based on the HADS (hospital anxiety depression scale), EDQ (early dementia questionnaire) and symptoms assessment parameters on weekly basis.
Results: Result showed that there was significant reduction in HADS score at the end of the study. Moreover, the sensitivity and specificity of the HADS was observed highly relevant to detect the level of anxiety and depression by obtaining ROC curve. Numerical analysis of the EDQ was also shown eye-catching differences in patient receiving Dr. Brain syrup improved their memory at the end of the study compared to placebo group.
Conclusions: This study prooves the efficacy and safety of the Dr. Brain syrup in improving the memory and reducing the level of anxiety and depression in particular diseased patients without any side effects.