Ayurveda strength and immunity enhancing protocol and immunity in health care workers : Clinical trial of an Ayurveda Intervention
- Conditions
- All healthy human volunteers of both sex between age group of 19-60 years.
- Registration Number
- CTRI/2020/07/026756
- Lead Sponsor
- All India Institute Of Ayurveda
- Brief Summary
Research Hypothesis:Standalone therapy with Ayurveda medicine as per AYUSH protocol/guidelines in an individual’s having risk of exposure to COVID-19 will help in preventing the infection by improving Bala (overall strength and Immunity) of the individual.
Null Hypothesis:There is no significant changes in Bala (overall strength and Immunity), including quality of life of an individual having risk of exposure to COVID infection, hence unable to prevent COVID infection after Ayurveda Intervention.
Alternate Hypothesis:There is significant changes in Bala (overall strength and Immunity), including quality of life of an individual having risk of exposure to COVID infection, hence able to prevent COVID infection after Ayurveda Intervention.
AimThe aim of this exploratory study is to explore the efficacy of Ayurveda intervention as per AYUSH protocol in preventing the COVID-19 infection to an individual’s having risk of exposure to COVID-19 infection.
Objective:· Primary objective - To explore the efficacy of an Ayuveda intervention, in terms of improving Bala (overall strength and Immunity), in turn may help in preventing COVID-19 infection.
· Secondary objective – Improvement in Quality of Life (QoL)
MethodologyHealth care workers of AIIA, having risk of exposure to COVID-19 infection (n=425) will be administered with Ayurveda intervention along with the preventive measures as advised by AYUSH ministry and conventional prevention measures for COVID-19 infection. Individuals will be enrolled for the study after taking the written informed consent from all participants. This study will be subjected for approval by the institutional ethics committee of AIIA. Participants will be observed for a period of 120 days for any Changes in Deha bala (physical strength), Agni bala (digestion and metabolism) and Chetasa Bala (psychological strength), patient reported outcomes, Quality of Life, incidence of infection with COVID-19. Also the appearance of respiratory and other symptoms of COVID-19, and ADR’s if any.
**Research Design:** Interventional study **Duration of Intervention: 60 Days** **Follow up: 60 Days**
**Total Duration of trial: 120 Days**
**Intervention-** Ayurveda intervention along with following preventive guidelines of both AYUSH and conventional medicine- A single arm study
Inclusion criteria:1. Patients of either sex aged 19-60 years
2. Only willing staff of AIIA having risk of exposure to COVID-19 infection.
3. Agrees not to self-medicate with chloroquine, hydroxychloroquine or other potential antivirals.
4. Individuals agree to give consent for participation
Exclusion criteria:1. Individuals with chronic comorbid conditions which has affected the Bala of the Individual.
2. Already suffering with severe respiratory allergies and other conditions which may create bias in the outcome results
3. Individuals found positive for COVID 19 during the course of medication. Defined as: temperature > 38 Celsius; cough; shortness of breath; sore throat; or, if available (not required), positive confirmatory testing for COVID-19
4. Previously diagnosed with COVID-19
5. Subjects on other prophylactic medications.
6. Concurrent condition that in the investigator’s opinion would jeopardize compliance with the protocol.
**Investigations:** The following investigations will be done before starting the intervention in order to assess any underlying condition and after completion of intervention to assess the overall effect of intervention on the body apart from subjective assessment.
Hb, TC, DC, ESR, SGOT, Blood urea, Lipid profile, IGG and IGM
Intervention: (for 60 days)1. Tab Samshamani Vati 250 mg 2 bid after food with warm water
2. AYUSH Kadha 40 ml BD empty stomach
3. Chyavanprash 03 GMS in the morning once a day
4. Application of Anu taila 2 drops in each nostril once a day after bath in the morning
5. Gargle with warm water mixed with rock salt and turmeric
6. AYUSH preventive guidelines for COVID 19 with Yoga and Pranayama
During follow up: (For 60 days)1. Only observation with routing preventive measures as mentioned above.
2. Individuals will be assessed intermittently at 30 days of period and follow up will be done for 60 days after completion of the intervention.
Mechanism of Action of InterventionAbove drugs have been chosen as they play a significant role in enhancing the strength and immunity of the individual. Sanshamani Vati has Guduchi (Amrita), as main content, which is a drug described under Vayah Sthapana Mahakashaya (C.S. Su-4/18) Rasayan (Bha. Pr.), Anu taila performs the action of local barrier to the entry of virus through the portal of nose, besides strengthening the mucosal barrier of the respiratory system and nourishing other tissues. Chyavanprasha is one of the time tested Ayurveda formulation used since ancient time to enhance the strength and immunity in general and of the respiratory and cardio vascular system in particular, Amalaki being the main ingredient of Chyavanprasha known for its higher concentration of Vitamin C which is considered as the best molecule in the prevention and management of Covid-19 infection. Ingredients of AYUSH kadha (decoction) are known for antimicrobial action in general and enhances the digestion and metabolism which indirectly plays a significant role in the maintenance of healthy immune system and overall strength of the individual. Ayurveda believes in the principle of Kshetra (Host) that is strengthening of the body so that the seed of the disease may find it infertile to grow and flourish. Strengthening the body tissues is providing the Yuktikrita bala (Acquired Immunity) to the individual so that the disease may either not flourish at all or even if it manifests, it may produce the disease in a very mild form with less discomfort to the body and results in early healing.
Drugs used in this study are as per the protocol mentioned by Ministry of AYUSH, Govt. of India. Drugs used are intended to improve the Bala (strength and immunity) of an individual to fight against the infection in turn preventing COVID-19 infection.
Guduchi has been studied and found to have immunomodulation activity, anti-inflammatory, anti- arthritic, anti-pyretic, anti-infective, anti-osteoporotic, anti-allergic, anti-oxidant, anti-neoplastic, radio-protective, hepatoprotective, anti-hyperglycemic, cardio-protective activity. [13]
Anu taila (Ashtanga Hr.Sutra sthana-20/37-38) if applied in the nostrils, it acts as barrier for entry of virus. Anu taila Nasya has only few scientific studies till now, there is no study focused on its immunity boosting and nourishing effects etc. [17],
Hence, knowing the efficacy of Ayurveda drugs to improve the overall strength and provide healthy immune system in health care workers which may prevent them from acquiring Covid-19 infection.
**Rescue Medication** – If the patient complains of any new complain or any existing disease worsens, then rescue medication as needed will be given to the patients in the supervision of the respective experts and it will be recorded in the study along with their dose and duration. The Ayurveda intervention will be continued after the resolution of the symptoms.
**Adverse events** – Adverse events if any developed during the usage of the intervention will be recorded.
**Restrictions -** The patients will be advised to strictly follow the dietary guidelines regarding food, food habits and life style advised to them by Ministry of AYUSH. “Ayurveda’s immunity boosting measures for self-care during COVID 19 crisisâ€
Withdrawal of the Patient –If the patient develops any adverse reaction or doesn’t want to continue with the study
Follow upThe patient’s will be assessed intermittently at 30 days of period and follow up will be done one month after completion of the trial.
Criteria for assessment· The subjective wellbeing of the individuals will be assessed.
· Bala assessment of an individual will be done by assessing the Deha bala by Vyayama Shakti (capacity to do the physical activity including exercise), Agni bala by Abhyavaharana and Jarana Shakti (Digestive capacity), Chetasa bala by self-assessment questionnaire
· To assess the effect objectively Specific lab investigations like IGG and IGM for immunity, SGOT for liver metabolism, Lipid profile for lipid metabolism, Blood urea for functioning of kidney, Hb% and TC, DC, ESR to assess status of any infection.
· Assessment of Quality of Life by using WHO SF-36 questionnaire
· The percentage of susceptible individuals developing infection of COVID-19
Source of data:literature both Ayurveda and Contemporary Science
Health care workers working at All India institute of Ayurveda New Delhi.
Statistical Data AnalysisSuitable Statistical analysis will be done.
Outcomes of Study
**Primary**
· Improvement in Bala of an individual
· Immuno-stimulation leading to non-development of symptoms of COVID- 19 in risk population working in Hospital set up.
Secondary
· Overall Improvement in Quality of Life
Previous research workAs COVID-19 is a recent infection outbreak, no researches have been done on the efficacy of Ayurveda interventions in health care workers. To the best of our knowledge, this is the first study of its kind.
Purpose - Any positive leads found in this study will provide breakthrough knowledge in stopping the epidemic of COVID-19 infections and decrease the morbidity and mortality related to the disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 425
- 1.Patients of either sex aged 19-60 years 2.Only willing staff of AIIA having risk of exposure to COVID-19 infection.
- 3.Agrees not to self-medicate with chloroquine, hydroxychloroquine or other potential antivirals.
- 4.Individuals agree to give consent for participation.
- 1.Individuals with chronic comorbid conditions which has affected the Bala of the Individual.
- 2.Already suffering with severe respiratory allergies and other conditions which may create bias in the outcome results 3.Individuals found positive for COVID 19 during the course of medication.
- Defined as: temperature > 38 Celsius; cough; shortness of breath; sore throat; or, if available (not required), positive confirmatory testing for COVID-19 4.Previously diagnosed with COVID-19 5.Subjects on other prophylactic medications.
- 6.Concurrent condition that in the investigator’s opinion would jeopardize compliance with the protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1 Improvement in Bala of an individual 4 Assessments at a gap of 30 days | Baseline 0 | Assessment 1 | Assessment 2 | Assessment 3 2 Immuno-stimulation leading to non-development of symptoms of COVID- 19 in risk population working in Hospital set up. 4 Assessments at a gap of 30 days | Baseline 0 | Assessment 1 | Assessment 2 | Assessment 3
- Secondary Outcome Measures
Name Time Method Improvement in quality of life 4 Assessment at a gap of 30 days
Trial Locations
- Locations (1)
All India Institute Of Ayurveda
🇮🇳West, DELHI, India
All India Institute Of Ayurveda🇮🇳West, DELHI, IndiaDr Santosh Kumar BhattedPrincipal investigator9414048459santoshbhatted@rediffmail.com