| CTRI Number |
CTRI/2025/06/088518 [Registered on: 10/06/2025] Trial Registered Prospectively |
| Last Modified On: |
07/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of diseases not named in ayurveda w.s.r to peripheral neuropathy and its ayurvedic line of management |
|
Scientific Title of Study
|
A conceptual and applied study on na hi sarvavikaranam namato asthi Dhruva sthitaha w s r to peripheral neuropathy. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sahana |
| Designation |
2nd Year Pg scholar |
| Affiliation |
Government Ayurveda Medical College and hospital M ysuru |
| Address |
Post graduate Department of Ayurveda Samhitha and siddhanta Government
Ayurveda Medical College and Hospital, Visvesvaraya circle, Sayyaji Rao Road,Mandi Mohalla, Mysuru KARNATAKA 570001 India
Mysore
KARNATAKA
570001
India |
| Phone |
7760899121 |
| Fax |
|
| Email |
sahanaboral22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vasudev Anandrao Chate |
| Designation |
Professor |
| Affiliation |
Government Ayurveda Medical College and hospital mysuru |
| Address |
Post graduate Department of Ayurveda Samhitha and siddhanta Government
Ayurveda Medical College and Hospital, Visvesvaraya circle, Sayyaji Rao Road,Mandi Mohalla, Mysuru KARNATAKA 570001 India
Mysore
KARNATAKA
570001
India |
| Phone |
9448150212 |
| Fax |
|
| Email |
vachate37@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sahana |
| Designation |
Pg scholar |
| Affiliation |
Government Ayurveda Medical College and hospital mysuru |
| Address |
Post graduate Department of Ayurveda Samhitha and siddhanta Government
Ayurveda Medical College and Hospital, Visvesvaraya circle, Sayyaji Rao Road,Mandi Mohalla, Mysuru KARNATAKA 570001 India
Mysore
KARNATAKA
570001
India |
| Phone |
7760899121 |
| Fax |
|
| Email |
sahanaboral22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda Medical College and Hospital Mysuru Karnataka India 570001 |
|
|
Primary Sponsor
|
| Name |
Dr Sahana |
| Address |
Post graduate Department of Ayurveda Samhitha and siddhanta Government
Ayurveda Medical College and Hospital, Visvesvaraya circle, Sayyaji Rao Road,Mandi Mohalla, Mysuru KARNATAKA 570001 India |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSahana |
Government Ayurveda Medical College and Hospital |
OPD Division, Ground floor Government Ayurveda Medical College and Hospital, Vishveshvaraya Circle, Sayyaji Rao Road,Mandi Mohalla, Mysore,570001,Karnataka
Mysore
KARNATAKA |
07760899121
sahanaboral22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Ayurveda Medical College and Hospital Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G64||Other disorders of peripheral nervous system. Ayurveda Condition: PADAHARSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | avagAhasvedaH, अवगाहस्वेदः | (Procedure Reference: Charaka Samhita Sutra 14th Chapter, Procedure details: Purvakarma: Abhyanaga with
Ksheerabala taila.Pradhanakarma: affected part will be
immersed in Sanjnasthapana
dashemani mahakashaya)
(1) Medicine Name: Sanjnasthapana dashemani mahakashaya, Reference: haraka Samhita Sutra Sthana fourth Chapter, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 2000(ml), Frequency: sos, Duration: 14 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sanjna Sthapana Mahakashaya, Reference: Charaka Sutra Sthana fourth Chapter, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -Sukhoshna Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
• 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. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |