| CTRI Number |
CTRI/2026/01/101462 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive
Process of Care Changes
Other (Specify) [Panchkarma Therapy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Panchkarma Procedure Approaches for Reducing Symptoms of Diabetic Peripheral Neuropathy |
|
Scientific Title of Study
|
A Randomized Clinical Study Comparing The Efficacy Of
Shashtika Shali Pinda Swedana With Panchatikta
Panchaprasritik Basti Vs Sarvanga Abhyanga 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 |
Dr Jitendra Shakya |
| Designation |
Pg Scholar |
| Affiliation |
National Institute Of ayurveda |
| Address |
Department of Panchkarma, National Institute of Ayurveda, Jaipur
Jorawar Singh Gate, Amer Road, Jaipur, 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9685660901 |
| Fax |
|
| Email |
jitendra.shakya2212@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kshipra Rajoria |
| Designation |
Assistant Professor (Sr) |
| Affiliation |
National Institute Of ayurveda |
| Address |
Department of Panchkarma, National Institute of Ayurveda, Jaipur
Jorawar Singh Gate, Amer Road, Jaipur, 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9001454100 |
| Fax |
|
| Email |
kshiprarajoria@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kshipra Rajoria |
| Designation |
Assistant Professor (Sr) |
| Affiliation |
National Institute Of ayurveda |
| Address |
Department of Panchkarma, National Institute of Ayurveda, Jaipur
Jorawar Singh Gate, Amer Road, Jaipur, 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9001454100 |
| Fax |
|
| Email |
kshiprarajoria@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Ministry of Ayush, Govt of India,
Jorawar Singh Gate, Amer Road
Jaipur - 302002 Rajasthan, India
|
|
|
Primary Sponsor
|
| Name |
National Institute Of ayurveda |
| Address |
Jorawar Singh Gate, Amer Road
Jaipur - 302002 Rajasthan, India |
| Type of Sponsor |
Other [National Institute of Ayurveda (De Novo), Ministry of Ayush, Govt of India] |
|
|
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 Jitendra Shakya |
National Institute of Ayurveda |
Department of Panchkarma OPD Room no. 2
Jaipur
RAJASTHAN |
9685660901
jitendra.shakya2212@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute of Ayurveda |
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 | Intervention Arm | Procedure | - | SHASHTIKA SHALI PINDA SWEDANA WITH PANCHATIKTA PANCHAPRASRITIK BASTI | (Procedure Reference: Charak Samhita chikitsasthana, Vataraktachikitsaadhyaya- 29/121, Procedure details: Swedana- ShaliShastika PindaSwedana(with Guduchyadi tail aAbhyanga)
Basti- Panchtikta Panchaprasritik basti before meals.
The total number of Basti administered will be 15 (1Basti on a daily basis).
Dosage –500 ml)
(1) Medicine Name: Guduchyadi tail, Reference: Charak Samhita chikitsasthana, Vataraktachikitsaadhyaya- 29/121, Route: Rectal, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 15 Days(2) Medicine Name: Panchtikta drugs, Reference: CharakSiddhisthana8/8., Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 480(ml), Frequency: od, Duration: 15 Days | | 2 | Comparator Arm | Procedure | - | SarvangaAbhyanga | (Procedure Reference: Charak Samhita chikitsasthana, Vataraktachikitsaadhyaya- 29/121, Procedure details: Sarvanga Abhyanga with Guduchyadi taila)
(1) Medicine Name: Guduchyadi taila, Reference: Charak Samhita chikitsasthana, Vataraktachikits aadhyaya- 29/121, Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with diabetic peripheral neuropathy
2. Participants willing and able to participate in this study for entire trial period with informed consent.
3. Participants fit for basti, shalishastikapindaswedana and sarvangaswedana
|
|
| ExclusionCriteria |
| Details |
1. Patient, suffering from any acute or chronic debilitating disease (conditions involving
cardiac, vascular, hematological, respiratory, hepatic, gastrointestinal, renal
functions,central nervous system. or psychiatric disorder or active cancer).
2. Type 1 Diabetes Mellitus or Uncontrolled diabetes mellitus
3. Patients with long term steroid treatment.
4. Participants Not fit for Basti, ShaliShastikaPindaswedana and SarvangaSwedana |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in timed up and go test TUG pre and post treatment |
outcome will be assessed at baseline and 2 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in Toronto Clinical Neuropathy Score pre & post treatment
Changes in the Diabetic Neuropathy Symptom score pre & post treatment
Changes in Biochemical parameters FBS PPBS LFT & RFT pre & post treatment |
outcome will be assessed at Baseline & 2 week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/07/2026 |
| 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
|
This randomized, active-controlled clinical study is designed to compare the efficacy of Shashtika Shali Pinda Swedana with Panchatikta Panchaprasritika Basti versus Sarvanga Abhyanga in patients suffering from Diabetic Peripheral Neuropathy. Eligible participants will be randomly allocated into two groups. Group A will receive Basti Karma using Panchatikta Panchaprasritika Basti (500 ml, rectal route, administered in the morning on an empty stomach) along with Shashtika Shali Pinda Swedana preceded by Guduchyadi Taila Abhyanga, administered daily for 15 days. Group B will receive Sarvanga Abhyanga with Guduchyadi Taila for 30 minutes daily for 15 days. The total duration of the clinical trial is 15 days, with a follow-up assessment conducted after 30 days post-treatment to evaluate the sustainability of therapeutic effects. The study aims to assess and compare the clinical efficacy of these Ayurvedic interventions in the management of diabetic peripheral neuropathy. |