Effect Of Unani formulation with massage in Diabetic nerve pai
- Conditions
- Health Condition 1: E134- Other specified diabetes mellituswith neurological complications
- Registration Number
- CTRI/2022/04/041831
- Lead Sponsor
- ational Institute of Unani Medicine Bengaluru
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Documented Diagnosed cases of Type 1 or 2 diabetes
Patients of either sex
Patients older than 20 years and less than 60 years of age
Stable glycemic control for 3 months i.e. HbA1c < 8%.
DSPN defined by:
Bilateral reduced or absent reflexes at the ankles
Bilateral impaired vibration, pinprick, fine touch or temperature perception in the distal lower extremities.
Persistent distal burning or dull pain in the feet
Persistent proximal aching pain in the legs
Paroxysmal electric, shooting, stabbing pain
Dysasthesias
Patient less than 20 years and more than 60 years
Physiological state as pregnancy and lactation.
Patients having abnormal blood urea, serum creatinine, SGOT, SGPT.
Other causes of neuropathy or lower extremity pain
Uncontrolled hypertension at screen (sitting systolic >160 mmHg and/or sitting diastolic >90 mmHg
Currently participating in another clinical study in which the subject is, or will be exposed to an investigational or non-investigational drug or device.
Pathological state such as cardiovascular diseases, renal diseases, hepatic diseases, peripheral arterial diseases.
Unwillingness or inability to comply the requirements of the protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method change in â?¢Vibration perception threshold <br/ ><br>â?¢Michigan neuropathy screening instrument <br/ ><br>â?¢Chronic Acquired Polyneuropathy Patient-Reported Index (CAPPRI) scales <br/ ><br>Timepoint: 30 days
- Secondary Outcome Measures
Name Time Method ilTimepoint: Nil