Effectiveness of physiotherapy combined with standard Ayurveda treatments (a personalized treatment regime with a combination of Kashaya, Arishta, pills and oils) versus physiotherapy with placebo in improving functional activities in ischemic stroke patients: A Randomized Controlled Trial

INTERVENTION: ‐The study will be a randomized, participant blinded, placebo‐controlled clinical trial. It will be conducted at the Ward 61 & 62, Professorial Unit, Teaching Hospital, Anuradhapura, Sri Lanka. ‐Eligible participants will be randomized in to two groups (Control group or Experimental group) with a 1:1 allocation ratio by using minimization technique. Participants will remain blinded to treatment allocation until the outcomes are analyzed. ‐ Experiment group (Group B) will undergo a combination of usual physiotherapy care and specific Ayurveda treatments. Ayurveda treatment regime consists of a patient individualized treatment protocol of oral medications (Kashaya, Arishta & Pills) and external application of herbal oils. All the Ayurveda drugs which will be used are in Ayurveda pharmacopoeia and are in current practice in government Ayurveda hospitals in Sri Lanka. Treatments will be continued up to six months. ‐Control group (Group A) will undergo usual physiotherapy care with placebo Ayurveda treatments. Black tea will be used as placebo Kashaya and Arishta. Finger millet powder and wheat flour will be used to make placebo pills. Coconut oil will be used as placebo oils. Treatments will be continued up to six months. Doses of interventions are as follows, Physiotherapy All the exercises will be done for 5‐15 repetitions, 2 sets with 10 seconds hold once a day for 5 consecutive days per week. Number of repetitions could be varying according to the individual’s disability level. Ayurveda medications Kashaya • Denimba Kashaya • Dasamul Kashaya Add 8 cups (2L) of Kashaya to 250 ml of water and boiled it until it reduces to 1 cup (250ml). Then, 125ml – mane 125 ml ‐ nocte Arishta • Dasa mul Ar CONDITION: Ischemic stroke PRIMARY OUTCOME: % change in global disability using Barthel Index [At the baseline, at the end of three months and six months of starting the treatments]; SECONDARY OUTCOME: % change in motor functions using the Motor Assessment Scale (MAS) [At the baseline, at the end of three months and six months of starting the treatments]; % change in risk of falls using the Berg Balance Scale (BBS) [ At the baseline, at the end of three months and six months of starting the treatments]; % change in ability to walk independently using New Functional Ambulation Category (FAC) [ At the baseline, at the end of three months and six months of starting the treatments]; []; []; INCLUSION CRITERIA: • Patients confirmed to have an ischemic stroke • Patients above 18 years of age * Both men and women • Barthel Index 0‐50 (severely disabled patients) • NIHSS score (The National Institutes of Health Stroke Scale Score) 5‐20 on admission. • Non‐ thrombolysis patients