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Homoeopathic treatment of pain in limbs in diabetic patients

Phase 2
Conditions
Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications
Registration Number
CTRI/2023/03/050267
Lead Sponsor
D.N.De Homoeopathic Medical college
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.Patients suffering from diabetic neuropathy for 3 months or more diagnosis confirmed by DNE > 3 clinical assessment.

2.Age between 30 and 65 years

3.Participants of either sex

4.Literate patients; ability to read English and/or Bengali, Hindi.

5.Illiterate people will be interviewed by the investigators maintaining adequate privacy to fill up the scales or questionnaires.

6.Providing written informed consent voluntarily.

Exclusion Criteria

1. Persons suffering from any other neurological disorders

2. DNE score 3 or less

3. Diabetic polyradiculopathy, diabetic amyotrophy, abnormality of gait, loss of arch with multiple fractures in tarsal bones wrist, foot drop.

4. Paralysis of III, IV, VI cranial nerve.

5. Neuropathy due to vitamin B12 deficiency to be determined by peripheral blood smear

6. Development of typical Charcot joints, particularly in the feet.

7. Complication of Diabetes (retinopathy, renal involvement or with history of recurrent acute complaints like hypoglycemia, keto-acidosis).

8. Immune-compromised patients.

9. Person taking homoeopathic medicine for any other cause

10. Vulnerable population - unconscious, too sick for consultation, differently abled, terminally ill or critically ill patients, mentally incompetent people

11. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure.

12. Pregnant and puerperal women, lactating mothers

13. Patients with the habit of tobacco chewing and/or smoking, alcoholism and/or any other form(s) of substance abuse and/or dependence.

14. Self-reported immune-compromised state

15. Already undergoing homoeopathic treatment for chronic disease within last 6 months

16. Simultaneous participation in any other clinical trials

17. Persons dependent on insulin or requiring insulin as per guideline of the Director of West Bengal Health Service whose HBA1C 10 or above

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
europathic total symptom score 6 (NTSS-6)Timepoint: At the baseline, and every <br/ ><br>month, up to 3 months
Secondary Outcome Measures
NameTimeMethod
Diabetic neuropathic examination (DNE) scoreTimepoint: At the baseline, and every <br/ ><br>month, up to 3 months;DN4 questionnairesTimepoint: At the baseline, and every <br/ ><br>month, up to 3 months;HbA1C%Timepoint: At the baseline and after 3 months;McGill pain short form questionnaireTimepoint: At the baseline, and every <br/ ><br>month, up to 3 months
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