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Clinical Trial for Diabetic Foot Ulcer through Siddha medicines

An Open Label Pilot Clinical Trial to Evaluate the Effectiveness of Siddha Herbo Mineral Formulation Vajirakandi Mathirai (Internal) and Mathan Thylam (External) for Madhumega Pun (Diabetic Foot Ulcer) - Nil

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/10/058661
Enrollment
10
Registered
2023-10-13
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E116- Type 2 diabetes mellitus with other specified complications

Interventions

Intervention1: Vajirakandi Mathirai and Mathan Thylam: Vajirakandi Mathirai (Internal) 1 tablet twice a day for 48 days and Mathan Thylam (External) Control Intervention1: Nil: Nil

Sponsors

National Institute of Siddha
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
1 To observe the changes as per Wagners classification tool and Photostatic wound assessment scale for Diabetic Foot ulcer from baseline to end of the treatment Timepoint: 1 YEAR

Secondary

MeasureTime frame
To observe the changes in the lab investigations from baseline to end of the treatmentTimepoint: 1 YEAR

Countries

India

Contacts

Public ContactDr G J Christian

National Institute of Siddha

christianvijila@gmail.com9962545930

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026