| CTRI Number |
CTRI/2026/02/104833 [Registered on: 26/02/2026] Trial Registered Prospectively |
| Last Modified On: |
26/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Study to Evaluate Ayurvedic Decoctions with Local Oil Massage for Diabetic Peripheral Neuropathy |
|
Scientific Title of Study
|
A Randomized Double Arm Comparative Clinical Study to
Evaluate the Efficacy of Dashamula Kashaya and
Mahamanjishtadi Kashaya Along with Sthanika Abhyanga in the
Management of Prameha Upadrava vis a vis Diabetic Peripheral
Sensory 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 Swarooparani |
| Designation |
Post Graduate Scholar |
| Affiliation |
AYURVEDA MAHAVIDYALAYA AND HOSPITALHUBBALLI |
| Address |
Department of Kayachikitsa Ayurveda Mahavidyalaya and Hospital Heggeri Extension Hubbali 580024
Dharwad
KARNATAKA
580024
India |
| Phone |
8123908416 |
| Fax |
|
| Email |
swarooparani651@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohammad Yaseen Hullur |
| Designation |
Associate Professor |
| Affiliation |
AYURVEDA MAHAVIDYALAYA AND HOSPITALHUBBALLI |
| Address |
Department of Kayachikitsa Ayurveda Mahavidyalaya and Hospital Heggeri Extension Hubbali 580024
Dharwad
KARNATAKA
580024
India |
| Phone |
8095744095 |
| Fax |
|
| Email |
yaseenhullur21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohammad Yaseen Hullur |
| Designation |
Associate Professor |
| Affiliation |
AYURVEDA MAHAVIDYALAYA AND HOSPITALHUBBALLI |
| Address |
Department of Kayachikitsa Ayurveda Mahavidyalaya and Hospital Heggeri Extension Hubbali 580024
Dharwad
KARNATAKA
580024
India |
| Phone |
8095744095 |
| Fax |
|
| Email |
yaseenhullur21@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Swarooparani |
| Address |
Department of Kayachikitsa Ayurveda Mahavidyalaya and Hospital Heggeri Extension Hubbali 580024 |
| 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 |
| Dr Swarooparani |
Ayurveda Mahavidyalaya and Hospital Heggeri Extension Hubbali 580024 |
Department of Kayachikitsa Ayurveda Mahavidyalaya and Hospital Heggeri Extension Hubbali 580024
Dharwad
KARNATAKA |
8123908416
swarooparani651@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ayurveda Mahavidyalaya and Hospital Ethical Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E114||Type 2 diabetes mellitus with neurological complications. Ayurveda Condition: PRAMEHA-UPADRAVAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Dashamoola Kashaya, Reference: Bhavaprakasha, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Ushnajala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Mahamanjishtadi Kashaya, Reference: Sahashrayogam, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Ushnajala), Additional Information: - | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shatapushpa churna, Reference: Bhavaprakasha Nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Days, anupAna/sahapAna: Yes(details: -Ushnajala), Additional Information: | | 4 | Intervention Arm | Procedure | - | aBya~ggaH, अभ्यंग | (Procedure Reference: Caraka Samhita, Procedure details: Sthānika Abhyanga was done with Chinchadi Taila, which was gently warmed by indirect heating to a lukewarm temperature and then applied over the affected area with gentle massage. )
(1) Medicine Name: Chinchadi taila, Reference: Sahashrayogam, Route: Topical, Dosage Form: Churna/ Powder, Dose: 15(ml), Frequency: od, Duration: 14 Days |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects of Type 2 Diabetes Mellitus on OHA Oral Hypoglycaemic Agents with
chronicity of 0to10 years will be included
Subjects of Diabetic peripheral neuropathy with Diabetic Neuropathy Symptom Score -
DNS 1to4 will be included
Subjects with Diabetic peripheral neuropathy between the age group of 40 to 65 years
irrespective of gender religion occupation and socioeconomic status will be included
Subjects with HBA1C level upto 10percent will be included
Subjects with FBS 120 to 200mg/dl PPBS 220 to 300 mg/dl will be included
Definition of fresh cases include freshly diagnosed and untreated cases of Diabetic
peripheral neuropathy
Definition of treated cases includes already diagnosed and treated cases of Diabetic
peripheral neuropathy who had voluntarily discontinued the treatment with the washout period of 7 days |
|
| ExclusionCriteria |
| Details |
Subjects of Type 2 Diabetes Mellitus on Insulin therapy and with complications like diabetic
nephropathy retinopathy infectious wounds gangrene and foot ulcers will be excluded
Subjects with age group below 40yrs and above 65yrs will be excluded
Subjects with HbA1C above 10percent and chronicity more than 10 yrs will be excluded
Subjects with uncontrolled diabetes mellitus ie FBS more than200mg/dL and PPBS more than 300 mg/dL will be excluded
Subjects with any other systemic disorders which interfere with the intervention will be
excluded
Subjects with other type of neuropathy like Autonomic and motor neuropathy are excluded |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
TO KNOW THE REDUCTION IN TORONTO CLINICAL SCORING OF NEUROPATHY AND FBS
PPBS
HBA1C LEVELS
Two Point Discrimination Test
VAS scale for pain assessment
|
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To know the reduction in Diabetic Neuropathy symptom score |
45 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 4 |
|
Date of First Enrollment (India)
|
09/03/2026 |
| 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
|
Diabetic
Peripheral Neuropathy is a common complication of Type 2 Diabetes Mellitus
characterized by numbness tingling burning sensation pain and sensory
impairment mainly in the lower limbs In Ayurveda this condition can be
correlated with Prameha Upadrava involving predominantly Vata Dosha This is a
randomized double arm comparative clinical study conducted on 40 subjects
diagnosed with Diabetic Peripheral Neuropathy Subjects will be randomly divided
into two groups with 20 subjects in each group Group A
will receive Dashamoola Kashaya along with Sthanika Abhyanga using Chinchadi
Taila
Group B will receive Mahamanjishtadi Kashaya along with Sthanika Abhyanga using
Chinchadi Taila The
duration of treatment will be 45 days Assessment
will be done based on Diabetic Neuropathy Symptom Score Toronto Clinical
Scoring System Visual Analogue Scale Two Point Discrimination Test and
laboratory parameters like FBS PPBS and HbA1c The study
aims to evaluate and compare the efficacy of both treatment protocols in
reducing the symptoms and improving the clinical condition of Diabetic
Peripheral Neuropathy Top of Form Bottom of Form
|