| CTRI Number |
CTRI/2026/02/103310 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
06/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To find out the effect of a selected Ayurvedic treatment in patients with diabetic peripheral neuropathy (a condition where diabetes causes damage to the nerves, leading to pain, tingling, and numbness in the hands and feet) |
|
Scientific Title of Study
|
EFFECT OF A SELECTED AYURVEDIC TREATMENT PROTOCOL IN DIABETIC 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 |
Sreelakshmi N L |
| Designation |
2nd year PG Scholar |
| Affiliation |
Government Ayurveda College Thiruvananthapuram |
| Address |
Department of Kayachikitsa
Government Ayurveda College Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India |
| Phone |
7559825573 |
| Fax |
|
| Email |
nlsreelakshmi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pravith N K MD Ay |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda College Thiruvananthapuram |
| Address |
Department of Kayachikitsa
Government Ayurveda College Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9946431132 |
| Fax |
|
| Email |
drnkpravith@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pravith N K MD Ay |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda College Thiruvananthapuram |
| Address |
Department of Kayachikitsa
Government Ayurveda College Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9946431132 |
| Fax |
|
| Email |
drnkpravith@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College Thiruvananthapuram
Kerala,India
Pincode:695001 |
|
|
Primary Sponsor
|
| Name |
Government Ayurveda College |
| Address |
Government Ayurveda College Thiruvananthapuram,Kerala,India,PIN:695001 |
| Type of Sponsor |
Other [Government Ayurveda College Thiruvananthapuram] |
|
|
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 Sreelakshmi N L |
Government Ayurveda College Thiruvananthapuram |
OP No 2
Department of Kayachikitsa
Government Ayurveda College Thiruvananthapuram
Kerala
PIN:695001
Thiruvananthapuram
KERALA |
7559825573
nlsreelakshmi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DRUG |
(1)Medicine Name:Manjishtadi Kashaya,Reference:Sahasrayoga,Route:Oral,Dosage Form:Kwatha/Kashaya,Dose:48(ml),Frequency :bd ,Bhaishajya Kal:Abhakta (30 minutes before food),Duration:7 days,Additional information:Along with Dhanyamladhara |
| Intervention |
DRUG |
(1)Medicine Name:Suntibaladwaya Kwatha,Reference:Chikitsa manjari,Route:Oral,Dosage Form:Kwatha/Kashaya,Dose:48(ml),Frequency:bd,Bhaishajya Kal:Abhakta(30 minutes before food),Anupana/Sahapana:Yes(Details-Ksheerabala 7 Avarti -10 drops,Reference:Ashtanga Hridaya),Duration:21 Days,Additional Information-Along with Abhyanga |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
PROCEDURE |
Abhyanga(Procedure details:Type of Snehana,Massaging with medicated oil over both upper and lower limbs)
(1)Medicine Name:Bala taila,Reference:Ashtanga Hridaya,Route:Topical,Dosage Form:Taila,Frequency:OD,Duration:30 minutes-21 Days |
| Intervention |
PROCEDURE |
Dhanyamla dhara(Procedure Reference:Sahasrayoga,Procedure details:Pouring of medicated liquid on both upper and lower limbs)
(1)Medicine Name:Dhanyamlam,Reference:Chikitsa Manjari,Route:Topical,Dosage form:Liquid,Frequency:OD,Duration:30 minutes-7 Days |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Age: 40-70 years
2.HbA1C lesser than or equal to 9.
3.Participants with clinically proven Diabetes Mellitus taking hypoglycemic medications
having symptoms of DPN. |
|
| ExclusionCriteria |
| Details |
1.Patients with diabetic foot with wounds, gangrene and other ulcerations.
2.Other types of DN like Autonomic, Focal and Proximal neuropathies are excluded.
3.Known case of severe systemic illness
4.Serum creatinine level greater than 1.3 mg/dL |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Reduction of score in (TCNS scale) from baseline.
2.Improvement from baseline in quantitative variables of Neuropathy Analyzer (Score). |
At the baseline,29th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="23"
Sample Size from India="23"
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 3 |
|
Date of First Enrollment (India)
|
20/02/2026 |
| 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 Yet Recruiting |
| 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 above study deals with assessing the effect of a selected ayurvedic treatment protocol in Diabetic peripheral neuropathy.It is a interventional single arm pre-post study design. Evaluation is made on the changes in TCNS score from baseline and also improvement from baseline in quantitative variables of Neuropathy Analyzer. |