Study to evaluate the efficacy of Dhanyamla Dhara in Diabetic Neuropathy

Phase 1/2

Not yet recruiting

Conditions: Other disorders of peripheral nervous system. Ayurveda Condition: PRAMEHA-UPADRAVAH,

Brief Summary: *Dhanyamla* is a medicine which can be used as multifaceted treatment. It is *Jeevana* (sustainer of life), *Daha Nashana* (mitigate burning sensation), *Vata Kapha Nashaka* (pacify vata & kapha), *Trishna hara* (mitigate thirst), *Deepana* (enhance digestion), *Jarana* (digestive), *Sramahara* (relieves fatigue) and *Klamahara* (relieves exhaustion).

Since the symptoms of Diabetic Peripheral Neuropathy such as pain, burning sensation, numbness and tingling sensation can be correlated to the involvement of vitiated *Vata* and *Kapha, Dhanyamla*, having properties of *Vata Kapha nashaka, Dahahara, Trisnahara,* etc can be used for the treatment of Diabetic Peripheral Neuropathy. Hence*, Sarvanga dhara* by *Dhanyamla* in Diabetic Peripheral Neuropathy is choosen for this study.

Recruitment & Eligibility

Inclusion Criteria

1.Metabolically stable diabetic subjects with symptomatic Diabetic Peripheral Neuropathy.
2.Subjects of all gender between the age group of 30-65 years.
3.Subjects fulfilling the diagnostic criteria.
4.Subjects whose HbA1C is between 6.5 to 10%.

Exclusion Criteria

1.Subjects where HbA1C >10% and <6.5%.
2.Subjects suffering from Type-1 Diabetes or Gestational Diabetes.
3.Pregnant and lactating women.
4.Subjects suffering from infectious diseases and non-healing ulcer/ ulcers of foot.
5.Any systemic illness that can interfere with the course of treatment.

Primary Outcome Measures

Name	Time	Method
1.Changes in Michigan Neuropathy Screening Instrument (MNSI) Questionnaire score	Before intervention 0th day \| After intervention 7th day \| Follow up 14th day
Assessment of the patients condition will be done based on	Before intervention 0th day \| After intervention 7th day \| Follow up 14th day
2.Changes in Toronto Neuropathy Clinical Scale (TCNS) Score	Before intervention 0th day \| After intervention 7th day \| Follow up 14th day
3.Changes in Visual Analog Scale (VAS)	Before intervention 0th day \| After intervention 7th day \| Follow up 14th day

Secondary Outcome Measures

Name	Time	Method
1. Changes in FBS value	2. Changes in PPBS value

Locations (1): Sri Sri College of Ayurvedic Science and Research Hospital Bangalore
🇮🇳
Bangalore, KARNATAKA, India
Sri Sri College of Ayurvedic Science and Research Hospital Bangalore
🇮🇳Bangalore, KARNATAKA, India
Dr Vaidyanath V S
Principal investigator
9495593392
drvaidyanathvs@gmail.com