1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response - Informed Consent Form
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - For individual participant data meta-analysis.
   


5. By what mechanism will data be made available?
   Response (Others) -  NOT YET DECIDED


6. For how long will this data be available start date provided 01-02-2021 and end date provided 01-02-2023?
   Response - Beginning 3 months and ending 5 years following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

This randomized controlled trial investigates the efficacy of Thumari (Securinega leucopyrus) cream compared to Povidone-Iodine in the management of diabetic ulcers (Madhumehajanya Vrana). The study aimed to evaluate the wound healing properties, microbial control, and overall therapeutic effect of these topical treatments in diabetic patients with non-healing wounds. 

A total of 141 patients with diabetic ulcers were screened, and 106 were included in the study. 96 patients were randomly divided into two groups: Group A-Treated group n=45 (Thumari cream) and Group B-control group n=51 (Povidone-Iodine). Both groups were treated with the respective topical agents, and the outcomes were evaluated based on subjective symptoms (pain, odour, itching, signs of infection), objective parameters (wound size), and laboratory investigations (microbial load, fasting blood sugar levels). 

The results revealed that Thumari cream significantly reduced pain (89.5%), odour (94.7%), and signs of infection (92.6%) compared to Povidone-Iodine, which showed relief in pain (73.7%) and odour (74.6%) but to a lesser extent. Both topical applications demonstrated a significant reduction in wound size, with Thumari cream showing an 84.8% improvement compared to 52.4% with Povidone-Iodine. Moreover, Thumari cream exhibited a greater reduction in microbial load and fasting blood sugar levels than Povidone-Iodine, although no significant difference was noted in the microbial load reduction between the two groups. 

The study concluded that both Thumari cream and Povidone-Iodine are effective in managing diabetic ulcers, with Thumari cream showing superior effects in wound healing and microbial control. Both agents were found to be safe, with no adverse drug reactions reported as local application. The study also emphasizes the potential of integrating Ayurvedic treatments like Thumari cream with modern wound care practices. Further research with larger sample sizes, longer treatment durations, and additional studies on the biological mechanisms of Thumari cream is recommended.