Clinical Trial for Diabetic Foot Ulcer through Siddha medicines

Phase 2

Not yet recruiting

Conditions: Type 2 diabetes mellitus with other specified complications,

Registration Number: CTRI/2023/10/058661

Lead Sponsor: National Institute of Siddha

Brief Summary: Diabetes mellitus is one of the largest global health emergencies of this century. It affects approximately 77 million people in India which is expected to rise to over 134 millionby 2045 . Diabetic complications are retinopathy, macular oedema, cataracts, glaucoma, neuropathy and ulceration of foot. Diabetic foot ulcer (DFU) is the most typical complication of diabetes mellitus with a poor prognosis due to micro and macrovascular changes (including neuropathy and peripheral vascular disease) as a result of uncontrolled sugar level. Diabetic foot is a severe public health issue, yet rare studies investigated its global epidemiology. The global diabetic foot ulcer prevalence was 6.3% which was higher in males than in females and higher in type 2 diabetic patients. The prevalence in Asia is 5.5 % . About 20% to 33% of costs related to diabetes mellitus are used for treatments of diabetic foot . Pathophysiology of Diabetic Foot Ulcer (DFU) depends on both host factors and microbial factors including drug resistance and virulence potentials . Though DFU is colonized by polymicrobial communities, Staphylococcus aureus is the predominant pathogen. S. aureus, with abundant biofilm formation, virulence factors, multidrug resistance inhibit wound healing and exacerbate wound infection. Several treatment methods, including Siddha formulations were reported for the management of DFU . However, the management of DFU is still challenging because of multidrugresistant polymicrobial isolates and their virulence, including biofilm. Numerous conventional therapies are available for managing DFUs. Amputation is the most common clinical result, occurring in 6/1000 patients annually . Amputations have diverse impacts on patients, including impaired physical function, psychosocial trauma, loss of employment and economic stress. To overcome with all the negative effects of amputation, limb saving treatment modalities are required where integration with other system of medicine is necessary for the benefit of the patient, whereas Siddha system has several internal and external medications for the management and treatment of DFUS. Saint Yugimuni has described the complication of Madhumegam as Avathaigal, which are ten in numbers. Ulceration of feet/ may be correlated with Avathaigal number eight . As per the evidence of Siddha legend T.V.Sambavasilva pillai Madhumega pun is denoted as Rasa pun. This study deals with the treatment modality of Siddha Herbo mineral formulation formulation Vajirakandi mathirai (Internal) and Mathan thailam (External) in Madhumega Pun (Diabetic foot Ulcer). The Siddha medicine has the potential to heal nearly 90% of diabetic wounds (Diabetic Foot Ulcers) and result in lower blood sugar levels. They may perhaps have a huge impact on the healing process, falling infection rates, amputations, plastic surgeries and humanising the overall quality of life, reducing the monetary burden of treating Diabetic foot Ulcer.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 10

Inclusion Criteria

Known case of type II DM with DFU 1 Age 30 to 65 years 2 Sex Males and Females 3 HbA1c level ranges from 8 to 14 percent 4 Patients taking medications (Integrated medicines or Allopathic) for DM II 5 Patient with Grading I and II of Wagners classification tool will be included in the study 6 Patient who are willing to participate in the trial will be included.

Exclusion Criteria

1 Patient with any signs and symptoms of Osteomyelitis 2 Ulcer with signs of gangrene 3 Known case of Varicose Ulcer 4 Ulcer in which bone and joints are involved.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1 To observe the changes as per Wagners classification tool and Photostatic wound	1 YEAR
assessment scale for Diabetic Foot ulcer from baseline to end of the treatment	1 YEAR

Secondary Outcome Measures

Name	Time	Method
To observe the changes in the lab investigations from baseline to end of the treatment	1 YEAR

Trial Locations

Locations (1): National Institute of Siddha
🇮🇳
Chennai, TAMIL NADU, India
National Institute of Siddha
🇮🇳Chennai, TAMIL NADU, India
Dr T Monika
Principal investigator
9488074819
tmoniabi92@gmail.com