Role of Dhanadanayanadi Kashay in neuropathy.

Phase 2/3

Not yet recruiting

• Conditions: Other specified polyneuropathies. Ayurveda Condition: PRAMEHA-UPADRAVAH,

• Registration Number: CTRI/2025/05/087823
• Lead Sponsor: Dr Neha Dipak More

Brief Summary

The current study aimed as randomised control parallel group trial comparing the efficacy of Dhanadanayanadi Kashay and Pregabalin in the management of Distal Symmetrical Polyneuropathy.Total 52 diagnosed patients of Distal Symmetrical Polyneuropathy are equally

divided into two groups,namely experimental and control group.The symptoms of Distal Symmetrical Polyneuropathy are numbness, tingling,burning sensations and pain in stocking -glove distribution affecting feets and hands.Dhanadanayanadi Kashay 96ml used as experimental group medicine for

single use in the morning empty stomach will be given for 3 months.Pregabalin used as control group medicine for single use at 7:00Pm will be given for 3 months. The study will be

conducted for 3 months.

clinical assessment after every month.

Diabetic neuropathy is a common complication of Diabetes Mellitus. Most common among diabetic neuropathies is Distal Symmetrical Polyneuropathy, accounting for about 75%.

Distal Symmetrical Polyneuropathy (DSPN) is a common form of peripheral neuropathy that primarily affects the distal portions of the extremities in a symmetrical pattern. In Ayurveda, diabetes mellitus is associated with "Prameha," which, when left untreated,

progresses to "Madhumeha," a chronic and incurable condition. The complications of diabetic

neuropathy are attributed to "Vataprakopa," presenting symptoms such as Toda, Vyatha, Shul, Supti, Shosha , which closely align with DSPN.In modern medicine line of treatment for neuropathy involves use of tricyclic antidepressants ,anti convulsants like pregabalin ,gabapentin,duloxetine which causes various side effects like dizziness,drowsiness,lack of coordination,blurred

vision,constipation,weight gain etc. again affecting quality of life.

Dhanadanayanadi Kashay is one of the Ayurvedic formulations mentioned in Sahastrayoga,which mainly have katu ,tikta rasatmak,katu vipaka and ushna viryatmak dravyas showing kapha-vaat shaman properties and by ushna virya mainly vaat shamak ,which can be used in diabetic neuropathy.It is easily available and cost effective in nature hence selected for the present study.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-09-05
• Study Start: 2025-10-06

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• 1.Age group within 40-70years.
• 2.Patients irrespective of gender will be included and who are willing to take medicine.
• 3.Patients haning TCNS score more than or equal to 6 and less than or equal to 11.
• 4.Patients having HBA1C upto 10%.
• 5.Type 2 DM patients presenting with any of the signs like pain,numbness, tingling sensation,burning sensation.

Exclusion Criteria

• 1)Patients having type1 DM.
• 2)Causes of neuropathy other than diabetes mellitus like alcoholic neuropathy, neuropathy due to vit.B12 difficiency,due to thyroidism etc.
• 3)Patients with K/C/0 – Tuberculosis,AIDS ,Mlignancies,Leprosy 4)Pregnant and lactating women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the effectiveness of Dhanadanayanadi Kashay in comparison with Pregabalin in Distal Symmetrical	3 Months
Polyneuropathy.	3 Months

Secondary Outcome Measures

Name	Time	Method
To assess efficacy of Dhanadanayanadi Kashay in management of distal symmetrical polyneuropathy in the parameters of Toronto Clinical Neuropathy Score	3 months
To study probable mode of action of drug of study.	3 months

Trial Locations

Locations (1)

Y.M.T.Ayurvedic Medical College and Hospital; 🇮🇳 Raigarh, MAHARASHTRA, India

Y.M.T.Ayurvedic Medical College and Hospital

🇮🇳Raigarh, MAHARASHTRA, India

Dr Neha Dipak More

Principal investigator

7020718428

nehamore01999@gmail.com