Professional Documents
Culture Documents
Common Inclusion
1. Any acute condition not clinically serious* in nature
Criteria
* See Point no. 2 of Exclusion criteria
1. Having undergone antibiotic treatment within 7 days prior to
enrolment in the study
2. Indications for referral to a specialist, like haemoptisis,
aspiration of a foreign body, heart attack, intestinal obstruction
etc.
Exclusion criteria
3. Patients known to be suffering from serious hypertension
4. Patients who abused stimulants or had an illness that make
the practical participation in the study difficult.
5. Other ongoing treatment which is likely to interfere in the
course of this treatment.
6. Pregnant and lactating mothers
7-10 days, with at least one follow up in this period (more follow
Follow-up period
ups are preferred for better assessment)
Study Product, Dose,
Route, Regimen
Is this already highly Study Product: Preference to be given to the Drugs enlisted in the
standardized? or do Essential Drugs List (EDL) (File attached)
practitioners have the
option to deviate from this Dose: Each dose of indicated medicine will consist of four globules
posology if/as appropriate? in sugar of milk (size no. 30); the potency will be increased in the
ascending order (if needed); and repeated as mentioned below:
If the described posology is
already established as • 6C: Not to be repeated >4 doses a day
'routine', this is OK, because
• 30: Not to be repeated >2 doses a day
the aim is to assess routine
• 200: Not to be repeated >1 dose a day
clinical practice.
• 1M & above: Once weekly (or as per need)
If this posology is NOT
routine, there is a potential Route: Oral
conflict with the aim to
evaluate routine practice. In Regimen: As followed in day to day routine; or as nature of illness
the latter case, I recommend demands (E.g: Rest in case of fever etc.)
to allow more freedom in
terms of posology
Duration of Preferably not more than 7-10 days; longer if case so demands
administration (with justification in case notes in latter case)
In case of complete resolution of the symptoms, the doctor should
Outcome assessment ask as what day this was the case and report this in the case
notes.
To be undertaken in consultation with the VC Team. The onset
days and symptom resolution days (if applicable) will be entered
Statistical Analysis manually into an appropriate software package, with a view to
enabling the duration of the acute disease/episode for each
patient.