To compare the efficacy of massage with a combination of Triphala powder and medicated fermented liquid against massage with Triphala powder alone in diabetic peripheral neuropathy.

Phase 2

• Conditions: Health Condition 1: G63- Polyneuropathy in diseases classified elsewhere

• Registration Number: CTRI/2022/06/042984
• Lead Sponsor: Vaidyaratnam PS Ayurveda College Kottakkal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 27 June 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Fulfills diagnostic criteria of Diabetic Distal Symmetric Polyneuropathy.

2. 35 -70 years age group.

3. Gender: No barrier

4. Participants who have given informed consent.

5. HbA1c > 6.5% at screening

6. Participants fit for rūkṣa�a karma.

Exclusion Criteria

1. Secondary Parkinsonâ??s disease.

2. Participants suffering from Type 1 DM, Gestational DM

3. Participants having FBS > 300mg/dl at screening

4. Participants having hypothyroidism, uraemia (identified at screening)

5. Known cases of other endocrine disorders, malignancy, liver disorders or other serious medical conditions

6. Participants suffering from foot ulcer/amputation other than toes

7. Pregnant and lactating women

8. Hypersensitivity of skin

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
europathy Total Symptom <br/ ><br>Neuropathy Impairment Score <br/ ><br>Semmes-Weinstein Monofilament testing <br/ ><br>Quantitative sensory testTimepoint: BT - Baseline <br/ ><br> <br/ ><br>AT - Till samyak ruksha lakshana/maximum of 14 days <br/ ><br> <br/ ><br>AF - 15th day after treatment

Secondary Outcome Measures

Name	Time	Method
Event evaluation scaleTimepoint: Each day during the procedure - From day 1 to till samyak ruksha lakshana is attained/maximum of 14 days;Samyak rūkṣa�a lakshana assessmentTimepoint: Each day after the procedure - From day 1 to till samyak ruksha lakshana is attained/ maximum of 14 days.;Selected biochemical parametersTimepoint: BT - Baseline <br/ ><br> <br/ ><br>AT - Till samyak ruksha lakshana/maximum of 14 days <br/ ><br> <br/ ><br>;Selected physical parametersTimepoint: BT - Baseline <br/ ><br> <br/ ><br>AT - Till samyak ruksha lakshana/maximum of 14 days <br/ ><br> <br/ ><br>AF - 15th day after treatment