A Randomised Open Labelled Controlled Clinical Study to evaluate the efficacy of Dhanyamla Dhara in Diabetic Neuropathy
Trial Snapshot
- Phase
- Phase 1/2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Assessment of the patients condition will be done based on
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 30.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
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.
Outcomes
Primary Outcomes
Assessment of the patients condition will be done based on
Time Frame: Before intervention 0th day | After intervention 7th day | Follow up 14th day
1.Changes in Michigan Neuropathy Screening Instrument (MNSI) Questionnaire score
Time Frame: Before intervention 0th day | After intervention 7th day | Follow up 14th day
2.Changes in Toronto Neuropathy Clinical Scale (TCNS) Score
Time Frame: Before intervention 0th day | After intervention 7th day | Follow up 14th day
3.Changes in Visual Analog Scale (VAS)
Time Frame: Before intervention 0th day | After intervention 7th day | Follow up 14th day
Secondary Outcomes
- 1. Changes in FBS value(2. Changes in PPBS value)