Subject: In-Practice Usage and Performance (IPUP) Study of Phlogam tablets;
Study code: IPUP/Phlogam/Maxxim /May’23

Inflammation, although a protective and restorative response, when becomes excessive or uncontrolled, results in delayed healing or chronic inflammatory conditions. Systemic enzyme therapy combined with Trypsin, Bromelain and Rutoside (TBR) have been extensively investigated as alternatives to conventional pharmaceutical treatments for post operative inflammation, pain and swelling post minor surgery and dental procedures. In most cases, the patients that received the enzymes demonstrated significant reductions in pain and inflammation and faster recovery rates compared to the placebo groups and the duration of healing was reduced by half in some instances.

In the case of a surgical wound, the normal prolific inflammation tends to be excessive and can become an impediment in achieving a rapid and remarkably scar free injury repair. Surgical wounds can benefit from TBR, as they can potentially reduce the pill-burden and hasten the recovery by aiding wound healing. TBR is believed to intervene in four different processes: the release of inflammatory mediators, the modulation of adhesion molecules, the dissolution of detritus and the activation of fibrinolysis with consequent improved healing. This, in context of the expected better risk/benefit ratio that TBR offers against conventional pharmaceutical treatments like non-steroidal anti inflammatory drugs (NSAIDs) and opioid analgesics, makes it a very attractive option.

Phlogam tablets are marketed by the ‘Maxxim ’ team of Sun Pharmaceutical Industries Ltd.

Although every product is marketed only after regulatory approval, it is important to know how it performs in day-to-day practice of individual medical practitioners. This retrospective study will help to assess the real-life performance of Phlogam in patients with post surgical inflammation.

We invite you to participate in this study. All you need to do is to report on a standard form about your experience with Phlogam in consecutive number of patients (to avoid any bias) whom you prescribe this product in the normal course of your practice. Thus, this is not an experimental/interventional study because the product will be prescribed and purchased as you and your patients normally do.

If you agree to participate, you will need to copy the relevant information from the suggested number of patient’s case papers, and investigational reports, if any (which we call source documents), on to the standard case report forms (which we call CRF).

A monitor will assist you in verifying the CRF with the source documents to ensure that the CRF signed by you are free from errors or omissions. Let us assure you that the CRF will not contain the patients’ names, so as to ensure confidentiality.

If any serious adverse events (AE) occur during ‘Phlogam’ therapy, you will be expected to report them to the monitor or to me immediately on the AE reporting form.

As you will be spending some extra time to keep, copy and verify these patients records, we offer to pay you by cheque a professional fee of Rs. {{$contractAmount}}/- , and accordingly on receiving the completed CRFs.