Date

2021-10-21

Protocol

Protocol changed

Item Changed

Intervention(s) planned

Previous Version

-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 Arishtaya • Bala Arishtaya • Ashwagandha Arishtaya 12.5-25 ml tds Pills • Yoga raja gugguluwa • Chandraprabha wati • Chandra kalkaya • Ashwagandha gruthaya • Thripala 1-2 pills tds (1 pill=5g) Oils • Watha widuranga tahilaya • Mahanarayana thailaya • Ashwagandha thailaya External application, massaging and fomenting of dorsal aspect of limbs of the affected side for 30 minutes on a daily basis. Same dosing regimen will be used in the control group using the relevant placebo component. Discharge plan (for both groups) Discharge will be decided by the on-call consultant physician (ward 61 & 62). There won’t be any extended hospital stay for the participants who are included in the study. After discharging, review visits and home treatment programs will be carried out. -After discharging from the hospital, all participants will be advised to visit the hospital on two weekly bases until the completion of three months for follow up and at the end of three months, hospital follow up visits will be reduced to one visit per month till the completion of six months. -All participants will be asked to continue their treatment program daily at home and adherence to treatment is checked by regular phone calls and by asking the patient to maintain a treatment diary. -Ayurveda treatments will be given by a member in the study team who is a consultant physician and a diploma holder in Ayurveda and has registration in practicing Ayurveda and traditional medicine at Ayurveda Education and Hospital Board of Department of Ayurveda, under the Ministry of Health and Indigenous Medicine, Sri Lanka. -Confirmation of the recruitment will be done by a consultant physician who is one of the members in the study team.

Next Version

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 block randomization. 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 Arishtaya • Bala Arishtaya • Ashwagandha Arishtaya 12.5-25 ml tds Pills • Yoga raja gugguluwa • Chandraprabha wati • Chandra kalkaya • Ashwagandha gruthaya • Thripala 1-2 pills tds (1 pill=5g) Oils • Watha widuranga tahilaya • Mahanarayana thailaya • Ashwagandha thailaya External application, massaging and fomenting of dorsal aspect of limbs of the affected side for 30 minutes on a daily basis. Same dosing regimen will be used in the control group using the relevant placebo component. Discharge plan (for both groups) Discharge will be decided by the on-call consultant physician (ward 61 & 62). There won’t be any extended hospital stay for the participants who are included in the study. After discharging, review visits and home treatment programs will be carried out. -After discharging from the hospital, all participants will be advised to visit the hospital on two weekly bases until the completion of three months for follow up and at the end of three months, hospital follow up visits will be reduced to one visit per month till the completion of six months. -All participants will be asked to continue their treatment program daily at home and adherence to treatment is checked by regular phone calls and by asking the patient to maintain a treatment diary. -Ayurveda treatments will be given by a member in the study team who is a consultant physician and a diploma holder in Ayurveda and has registration in practicing Ayurveda and traditional medicine at Ayurveda Education and Hospital Board of Department of Ayurveda, under the Ministry of Health and Indigenous Medicine, Sri Lanka. -Confirmation of the recruitment will be done by a consultant physician who is one of the members in the study team.