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Clinical Trials/CTRI/2025/06/088518
CTRI/2025/06/088518Not yet recruitingPhase 2/3

A conceptual and applied study on na hi sarvavikaranam namato asthi Dhruva sthitaha w s r to peripheral neuropathy.

Dr Sahana1 site in 1 country30 target enrollmentStarted: May 7, 2025Last updated:

Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
assessing relief in the symptoms of Peripheral Neuropathy like Numbness, Paraesthesia, burning sensation and Impaired senation to pain vaibration,touch etc

Study Overview

Brief Summary

The entire system of Ayurveda is based on Trisutra. These Hetu, Linga and Aushadha are specific for both Swastha Rakshana and Atura Prashamana. Acharyas have mentioned Roga and Rogi Pareeksha for the purpose of treatment of many diseases mentioned(named) in classics but because of their multitudinous nature, diseases are innumerable and some diseases like Phiranga and Upadamsha are emerging along with Kala, so it is not possible to name all the diseases and only some diseases were explained with nomenclature whereas rest were stated as Anuktha vyadhi’s. In classical text acharya stated that Physician should not be ashamed of one’s inability to name a disease by stating “na hi Sarva vikaranam namato asthi dhruvam sthitha". This innumerability of diseases is because, the same vitiated dosha causes various disorders according to variations in etiology and location, so physician should initiate any treatment after acquiring complete and rational knowledge of the Prakruthi, Adhishtana, Samutthana of the diseases and physician does not get confused in actions. The proper insight of this shloka becomes the base for treating newly emerging diseases, as time changes emerging of new diseases like Dengue, Covid-19, etc are become challenges for Ayurveda physician such one disease is Peripheral neuropathy. Peripheral neuropathy is common in patient with DM, HTN and chronic alcohol or Tobacco chewers with impairment in function and quality of life, it is caused due to damage of nerves located outside of the brain and spinal cord (peripheral nerves) with symptoms like sensation of numbness, tingling sensation, sharpness or burning that begins in feet and spreads. Some time it also includes pain typically involving lower extremities with hyperesthesia some time paraesthesia and dysesthesia (Sanjna nasha) may be present. In the untreated condition may cause Neuropathic foot ulcer at last leads to foot amputations. In epidemiological studies from India from various regions the overall prevalence of Peripheral Neuropathy varied from 5 to 2400 per 10,000 population. As it is one among the newly emerging disease in contemporary science, nomenclature of this disease is not available in Ayurvedic classical text. So, the physician should first diagnose the disease with Roga and Rogi Pariksha and then select proper medicine with Yukti to attain the Yashas (fame). Hence in the present study effort is made to standardize the Samprapti and Chikitsa of Peripheral Neuropathy on the basis of “Na Hi Sarvavikaranam namato asthi dhruva sthitha" concept.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Not Applicable

Eligibility Criteria

Ages
40.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Peripheral neuropathy caused by Diabetes,HTN,Alcohol,Tobacco will be selected.
  • • Subject with mild (15 to 20 V) to moderate (20 to 25V) VPT test will be selected.
  • • Subject with any 2 subjective parameters and objective parameter will be selected.

Exclusion Criteria

  • • Subjects with secondary complication which interfere the treatment.
  • • Subjects with other complications of diabetes mellitus like diabetic nephropathy, retinopathy, infectious wounds, gangrene and foot ulcers will be excluded.
  • • Subjects with uncontrolled diabetes mellitus i.e. FBS greater than 200mg/dL and PPBS greater than 300 mg/dL will be excluded.
  • • Subjects with uncontrolled HTN greater than 160/110 mmhg will be excluded.
  • • Subject with alcohol and tobacco withdrawal symptoms.
  • • Subjects with any other systemic disorders which interfere with the intervention will be excluded.
  • • Pregnant women & lactating mother.

Outcomes

Primary Outcomes

assessing relief in the symptoms of Peripheral Neuropathy like Numbness, Paraesthesia, burning sensation and Impaired senation to pain vaibration,touch etc

Time Frame: 0 th day and 15 th day

Secondary Outcomes

  • assessing relief in the symptoms of Peripheral Neuropathy like Numbness, Paraesthesia, burning sensation and Impaired senation to pain vaibration,touch etc.(0 th day and 15 th day)
  • Overall relief in symptoms of Peripheral Neuropathy and Improvement in Quality of Life(15 th day)

Investigators

Sponsor
Dr Sahana
Sponsor Class
Other [self]

Study Sites (1)

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