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A Study Comparing Ayurvedic Herbal Smoke Therapy and Oxygen Exposure Therapy For Faster Healing of Diabetic Foot Ulcer

A Randomized Comparative Clinical Study to Evaluate The Efficacy of Vranadhoopan And Hyperbaric Oxygen Therapy In The Management of Diabetic Foot Ulcer - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097191
Enrollment
32
Registered
2025-11-11
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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: Group A Vranadhoopan with Nirgundyadi Dhoop: After cleaning the wound with antiseptic solution, varti made up from nirgundyadi dhoopa exposed on the wound throgh funnel shaped devise fo

Sponsors

Dr Jignesh Babubharthi Goswami
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age Group-Patients between 18 to 70 years with clinically diagnosed Diabetic Foot Ulcer. Type of Ulcer Presence of chronic, non-healing Diabetic Foot Ulcer for at least 2 Weeks. Size of the wound greater than 4 sq cm to less than 10sq cm. Wound Classification-Wagner classification Grade 1 to 3 ulcers (no gangrene). Blood Sugar Levels- HbA1c less than 7 percent. Irrespective of age gender Religion Occupation and economic status.

Exclusion criteria

Exclusion criteria: Age Below 18 and Above 70. Size of wound less than 4 sq cm and greater than 10 sq cm. Severe Ulcers, Wagner’s Grade 4 and 5 ulcers (gangrene or extensive necrosis). Uncontrolled Diabetes HbA1c greater than 7 percent. Patients with wounds other than Diabetic wounds. Any comorbid condition except diabetes. Pregnant lady & lactating women. Diagnosed cases of HIV and HbsAg.

Design outcomes

Primary

MeasureTime frame
Objective criteria Bates Jensen Wound Assessment Tool Subjective Criteria VRS (Verbal Rating Scale) for Pain Burning sensation and Itching SensationTimepoint: Duration 15 Days or up to healing Whichever is less Follow up Up to 1 month every 7 days

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDr Sanjay L Trivedi

G. J. Patel Institute of Ayurvedic Studies and Research

drsanjaytrivedi888@gmail.com9428628046

Outcome results

None listed

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