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Title and abstract |
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Include How participants were allocated to interventions (e.g., “random allocation,” “randomized,” or “randomly assigned”)
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Introduction |
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Background |
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Scientific background and explanation of rationale. |
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Why the study (what are you trying to prove):
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To provide evidence of effectiveness
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To provide references for existing beliefs
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To provide references to existing literature on the topic
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To furthering the science (in case of new or modified interventions or approach)
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To enhance the existing knowledge base for a known intervention
Why the intervention – give the scientific literature / report existing practice |
Methods |
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Define what you mean by the disease that you are trying to intervene, is it Diabetes or Prameha, it is important to note that both are not interchangeable.
Are they interchangeable? If yes provide reference - for example if all participants having the symptoms of prameha mentioned in Ayurvedic classical texts had fasting blood sugar level above 120 mg dl.
Are the patients stratified by any factor for example:
Western Biomedicine generally stratifies patients based on Age, Gender, and Stage or Severity of disease.
Ayurveda allows stratification of patients in many ways like dooshyam (tissues), desa (type of environment), balam (Strength), kalam (time) etc
Please explain the basis of stratification. |
Participants |
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Eligibility criteria for participants and the settings and locations where the data were
Collected |
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Interventions |
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Precise details of the interventions intended for each group and how and when they were actually administered |
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Intervention in Ayurveda is a combination of aushadis (medicine/treatment), anna (diet), and ahara (lifestyle).
The intervention is effected through a dynamic interaction of the following four pillars:
Doctor
Drug (In case of Manufactured drugs - shelf life, date of manufacture etc)
Paramedic
Patient
Ayurveda gives precise definitions/ideal qualities desired in each of the above, a scale of reference needs to be developed for measuring these; this should be documented clearly in order to arrive at realistic conclusions on efficacy.
Until such a scale is developed through a consultative process, it is desirable to document the skill and competences of the Doctor and Paramedic administering the treatment and quality of the medicine (manufacturer details etc)
The anticipated time to desired outcome and definition of the desired outcome, both as per ayurveda needs to clearly spelt out. |
Objectives |
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Specific objectives and hypotheses |
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Are you trying to prove your treatment is better/equivalent (safer, cost-effective, and more effective) than any current treatment?
Are you trying to standardize the treatment for a disease?
Are you trying to strategize a new treatment for a disease?
(e.g. It is desirable not claim hypoglycemic efficacy better than an available drugs, because hypoglycemic effect is not something ascribed to the drug in any of the Ayurvedic classical literature in the first place and no conclusive evidence is available to state that hypoglycemic effect translates completely into a reduction in the symptoms that define a particular disease according to ayurveda, but try to compare the efficacy in terms of the defined disease that you have diagnosed (in Ayurveda terms) in the participant with a available standard treatment) |
Outcomes |
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Clearly defined primary and secondary outcome measures and, when applicable, any methods used to enhance the quality of measurements (e.g., multiple observations, training of assessors). |
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What are you expecting as the outcome of the experiment? Define relief on Ayurveda terms and how to measure relief? Use only this to evaluate the experiment. (You need to produce conclusive evidence of whatever statement you make)
Clearly state the Time to desired outcome and definition of the desired outcome. |
Sample size |
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How sample size was determined and, when applicable, explanation of any interim analyses and stopping rules. |
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Randomization
Sequence generation |
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Method used to generate the random allocation sequence, including details of any restriction (e.g., blocking, stratification). |
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Only stratified randomization is possible as a particular disease in western biomedicine may fall under different disease definition in Ayurveda.
First Define strata based on Ayurveda definitions, followed by stratified randomization, then assigned either to an Ayurveda system vs allopathic Drug. |
Allocation concealment |
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Method used to implement the random allocation sequence (e.g., numbered containers or central telephone), clarifying whether the sequence was concealed until interventions were assigned. |
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Implementation |
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Who generated the allocation sequence, who enrolled participants, and who assigned participants to their groups? |
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Blinding (masking) |
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Whether or not participants, those administering the interventions, and those assessing the outcomes were blinded to group assignment. If done, how the success of blinding was evaluated. |
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Statistical methods |
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Statistical methods used to compare groups for primary outcome(s); methods for additional analyses, such as subgroup analyses and adjusted analyses. |
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Results |
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Participant flow |
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Flow of participants through each stage (a diagram is strongly recommended). Specifically, for each group report the numbers of participants randomly assigned, receiving intended treatment, completing the study protocol, and analyzed for the primary outcome. Describe protocol deviations from study as planned, together with reasons. |
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| Recruitment |
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Dates defining the periods of recruitment and follow-up. |
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Baseline data |
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Baseline demographic and clinical characteristics of each group. |
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Numbers analyzed |
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Number of participants (denominator) in each group included in each analysis and whether the analysis was by “intention to treat.” State the results in absolute numbers when feasible (e.g., 10 of 20, not 50%). |
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Outcomes and estimation |
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For each primary and secondary outcome, a summary of results for each group and the estimated effect size and its precision (e.g., 95% confidence interval). |
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Primary Endpoints should ideally be Ayurveda parameters (when does ayurveda says the disease has been cured) Subjective parameters could be converted into an event and measured objectively without bias if the assessor is efficiently blinded.
Co-primary or Secondary Endpoints: Could be western parameters, this will help over a period of time in generating valid evidence of correlations between Ayurveda and Western Biomedical parameters |
Ancillary analyses |
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Address multiplicity by reporting any other analyses performed, including subgroup analyses and adjusted analyses, indicating those prespecified and those exploratory. |
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Adverse events |
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All important adverse events or side effects in each intervention group. |
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Discussion |
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Interpretation |
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Interpretation of the results, taking into account study hypotheses, sources of potential bias or imprecision, and the dangers associated with multiplicity of analyses and outcomes. |
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Generalizability |
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Generalizability (external validity) of the trial findings. |
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Overall evidence |
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General interpretation of the results in the context of current evidence |
