Effect Of Ashwagandha Churna In Diabetic Neuropathy

Phase 3

Not yet recruiting

Conditions: Type 2 diabetes mellitus with neurological complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH,

Registration Number: CTRI/2023/09/058073

Lead Sponsor: Dr Ayush Dhankhar

Brief Summary: - Diabetic Neuropathy (DN) is serious diabetic complication and may affect about 50% to 90% of diabetic patients, out of these, 15% to 30% suffers from painful Diabetic Neuropathy. In *Ayurveda, Madhumeha Vyadhi*is nearly similar with Diabetes mellitus. The *Upadravas* of *Madhumeha*like *Daha, Harsha, Suptata, Shoola*, are similar with the symptoms of Diabetic Neuropathy. Pathological features of Diabetic Neuropathy can occur in peripheral nerves that includes axonal degeneration of both myelinated and unmyelinated fibres. In myeline sheath discontinuity, *Ashwagandha* helps to repair myelin sheath as per prior research works. Classical texts of Ayurveda have mentioned *Shodhana* and *Shamana* for the management of *Prameha* hence, here is an effort made to find a simple remedy which is cost effective.

- Ashwagandha have the properties like neuroprotective, synaptic & neurotic regenerative, myelin sheath repair, analgesic and anti-inflammatory, so it will be helpfull in reducing the symptoms of the DN.

- Objectives of the study are to evaluate the effect of Ashwagandha Choorna and Dashmoola Kwatha individually and compare the effects of both in the management of*Madhumeha* w.s.r. to Diabetic Neuropathy.

- It is a Randomised Controlled Clinical Trial. 40 patients of Diabetic Neuropathy will be selected incidentally and randomly assigned into two groups; Group â€˜Aâ€™ and â€˜Bâ€™ by software generated chart.

- Group A and group B patients will be given *Ashwagandha Churna and Dashmoola Kwatha* repectively.

- Subjects will be assessed on the basis of TCNS (Toronto Clinical Neuropathy Score) Score and VPT Value (Vibration perception threshold).

- Total Study duration will be 60 days and contain 4 visits (0th day, 15th day,30th day, 60th day.), which includes administration of trial drug for 30 days and post medication follow up on 60th day. After study, data will be collected from case report form (CRF) and statistically analyzed by using appropriate parametric and non-parametric tests and results will be obtained.

- On that basis of results, conclusion will be drawn.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

1.Patients having cardinal symptoms of Madhumeha Upadrava like Daha, Harsha, Suptata and Shula will be selected.
2.Diagnosed case of Type 2 Diabetic Neuropathy will be included.
3.Mild to moderate Neuropathy patients having Toronto score between 6 to 11 will be included.
4.Both fresh and treated cases will be included in the study.
5.On-going oral hypoglycaemic agents will be continued during study.
6.No other neuropathy managing drugs are allowed during study period.

Exclusion Criteria

1.IDDM (Type 1 DM) will be excluded from study.
2.Diabetic patients with chronic alcoholism will be excluded.
3.Pregnant and lactating women will be excluded.
4.Patient with any other serious condition which have negative impact on the nerves like Meningitis/encephalitis/Polio etc.
will be excluded.
5.Patient having any other associated clinical condition like Dementia, Parkinson, Stroke which influence peripheral nerve function will be excluded.
7.Medical/Surgical condition limiting functional mobility.
8.Non ambulatory patients.
9.Patients who are not willing to participate / consent.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effect of trial drug in classical symptoms of Diabetic Neuropathy and neuro-regeneration assessed by Toronto clinical neuropathy score and Vibration perception Threshold(VPT)	15day,30day, 60day

Secondary Outcome Measures

Name	Time	Method
Safety of Trial drug & Adverse drug Reaction & Aggravation of the Symptoms of Diabetic Neuropathy	15day,30day,60day

Trial Locations

Locations (1): Padma Ayurvedic Hospital And Research Centre
🇮🇳
Bagalkot, KARNATAKA, India
Padma Ayurvedic Hospital And Research Centre
🇮🇳Bagalkot, KARNATAKA, India
Dr Ayush Dhankhar
Principal investigator
7665144279
dr.ayushdhankhar@gmail.com