| CTRI Number |
CTRI/2025/07/090583 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
MATRABASTI PADABHYANGA AND SRINRIPATIVALLABHA RASA IN NUMBNESS AND BURNING SENSATION IN THE FOOT |
|
Scientific Title of Study
|
AN OPEN LABEL RANDOMIZED CONTROLLED CLINICAL STUDY TO EVALUATE COMBINED EFFECT OF MATRABASTI,PADABHYANGA AND SRINRIPATIVALLABHA RASA 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 |
DrVijayajyoti Sagarappa Janakapuri |
| Designation |
PG in Kayachikitsa Department |
| Affiliation |
JSS Ayurveda Medical College and Hospital Mysore |
| Address |
Opd 1 JSS Ayurveda Medical College and Hospital #41/E,Lalithadripura Road
Mysuru
Karnataka
570028
Opd 1 JSS Ayurveda Medical College and Hospital #41/E,Lalithadripura Road
Mysuru
Karnataka
570028
Mysore
KARNATAKA
570028
India |
| Phone |
8197598030 |
| Fax |
|
| Email |
Vijayajyotivijayajyoti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Deepa C Patil |
| Designation |
Professor, department of PG studies in Kayachikitsa |
| Affiliation |
JSS Ayurveda Medical College and Hospital Mysore |
| Address |
Opd 1 JSS Ayurveda Medical College and Hospital #41/E,Lalithadripura Road
Mysuru
Karnataka
570028
Opd 1 JSS Ayurveda Medical College and Hospital #41/E,Lalithadripura Road
Mysuru
Karnataka
570028
Mysore
KARNATAKA
570028
India |
| Phone |
988645005 |
| Fax |
|
| Email |
deepsmysore@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepa C Patil |
| Designation |
Professor,Department of PG studies in Kayachikitsa |
| Affiliation |
JSS Ayurveda Medical College and Hospital, Mysore |
| Address |
Opd 1 JSS Ayurveda Medical College and Hospital #41/E,Lalithadripura Road
Mysuru
Karnataka
570028
Opd 1 JSS Ayurveda Medical College and Hospital #41/E,Lalithadripura Road
Mysuru
Karnataka
570028
Mysore
KARNATAKA
570028
India |
| Phone |
988645005 |
| Fax |
|
| Email |
deepsmysore@gmail.com |
|
|
Source of Monetary or Material Support
|
| Opd 1 JSS Ayurveda Medical College and Hospital #41/E,Lalithadripura Road
Mysuru
Karnataka
570028 |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Opd 1 JSS Ayurveda Medical College and Hospital #41/E,Lalithadripura Road
Mysuru
Karnataka
570028 |
| Type of Sponsor |
Other [NIL] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vijayajyoti Sagarappa Janakapuri |
JSS Ayurveda Medical College and Hospital |
Opd 1 JSS Ayurveda Medical College and Hospital #41/E,Lalithadripura Road
Mysuru
Karnataka
570028
Mysore
KARNATAKA |
8197598030
Vijayajyotivijayajyoti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL HUMAN 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. Ayurveda Condition: PRAMEHA-UPADRAVAH, (2) 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 | Drug | Classical | | (1) Medicine Name: Srinripati vallaba rasa, Reference: Baisajya Ratnavali Grahani Aadhyaya, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: sukhoshnajala), Additional Information: - | | 2 | Intervention Arm | Procedure | - | Matrabasti | (Procedure Reference: Charaka samhita siddhistana, Procedure details: Matrabasti for 9 days)
(1) Medicine Name: Dhanvantara gritha, Reference: Astanga Hridaya Prameha chikitsa adhyaya, Route: Rectal, Dosage Form: Ghrita, Dose: 60(ml), Frequency: od, Duration: 9 Days | | 3 | Intervention Arm | Procedure | - | Padabhyanga | (Procedure Reference: Charaka Samhita , Procedure details: Padabhyanga for 9 days )
(1) Medicine Name: Chandanadi taila , Reference: Sahasrayogam, Route: Topical, Dosage Form: Taila, Dose: 0(NA), Frequency: bd, Duration: 9 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Day(s) |
| Age To |
70.00 Day(s) |
| Gender |
Both |
| Details |
Subjects fulfilling diagnostic criteria.
Subjects with HbAlc between 7% to 11%.
Subjects between the age group of 30-70 years irrespective of gender, religion and socio-economic status.
Both fresh and treated cases.
(Fresh case - include freshly diagnosed and untreated cases of DPN.Treated case - include already diagnosed and treated cases of DPN who had voluntarily discontinued the treatment with the flush out period of 7
days). |
|
| ExclusionCriteria |
| Details |
Subjects with other complications of Diabetes mellitus like nephropathy, wounds, foot ulcers and gangrene.
Stage 5 of Diabetic Peripheral Neuropathy.
Pregnant Women and Lactating Mothers.
Subject with any other systemic disorders which interfere with the intervention such as Cardiac Disorder, Cancer, Arterial Diseases, Alcoholism, Drug abuse, Renal insufficiency and Hepatitis. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reducing sign and symptoms of Diabetic Peripheral Neuropathy through Matrabasti with Dhanvantaragritha,Padabhyanga with Chandanadi taila and Srinripativallabharasa |
Reducing sign and symptoms of Diabetic Peripheral Neuropathy through Matrabasti with Dhanvantaragritha,Padabhyanga with Chandanadi taila and Srinripativallabharasa |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reducing of blood glucose level |
In 3 month of duration |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
25/07/2025 |
| 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="0"
Months="11"
Days="1" |
|
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
|
Diabetes Mellitus is a metabolic disorder of multiple etiologies. It is characterized by chronic hyperglycemia together with disturbance of carbohydrate, fat and protein metabolism resulting from defect of insulin secretion, insulin action or both.These are associated with the development of specific microvascular complication such as retinopathy, nephropathy and neuropathy.
Diabetic Peripheral Neuropathy[DPN] is one of the most common microvascular complication of Diabetes Mellitus and a major cause of morbidity. About 50% of Diabetic population are affected by Diabetic Peripheral neuropathy[DPN]. Patients with Type 2 Diabetes Mellitus are more often affected than those with Type1. In India, prevalence of Diabetic Peripheral Neuropathy ranges from 15 to 60%.
The TORONTO consensus meeting, defined Diabetic Peripheral Neuropathy[DPN] as asymmetrical and length-dependent sensorimotor polyneuropathy attributed to metabolic and micro-vascular alteration, as a result of long-standing hyperglycemia and metabolic derangements.
Common clinical features of Diabetic Peripheral Neuropathy[DPN] are diminished perception of vibration sensation distally, glove and stocking impairment, loss of tendon reflexes in lower limbs, paranesthesia in the feet(and, rarely, in the hands), pain in the lower limbs(dull, aching and/or lancinating, worse at night, and mainly on the anterior aspect of the legs), burning sensation in soles of the feet, cutaneous hyperesthesia and an abnormal gait and often associated with a sense of numbness in the feet. Management of Diabetic Peripheral Neuropathy includes strict glycemic control(life style modification and intensive insulin therapy) anticonvulsants, antidepressants and opiates. But the treatment is unsatisfactory in most of the respect. Hence its a need of hour to throw a light on effective and feasible treatment for Diabetic Peripheral Neuropathy[DPN].
Based on the clinical features of Diabetic Peripheral Neuropathy[DPN], it can be inferred that there is vitiation of Vata Pitta pradhana tridosha.
Basti is the prime treatment modality for Vata vyadhi. Acharya Sushrutha quotes that Basti is not only indicated for Vata Dosha, but also beneficial for Pitta, Kapha and Raktha Doshas. In present study, Dhanvantara Gritha mentioned in Astanga-Hrudaya Prameha chikista, indicated in Prameha pidaka, Madhumeha, Shotha and Vatashonita it is selected for Matra Basti. Focusing on the clinical feactures of Diabetic Peripheral Neuropathy[DPN], Chandanadi taila is selected for Padabhyanga, it is indicated in Angadaha and vatarakta.
Srinrupativallabha Rasa mentioned in Grahani Rogadhiraka of Bhaishajya Ratnavali having indication in Prameha,Daha,Vatarakta,Shotha also having karma of Ayushya, Balya & Veerya vardhaka is selected as the Shamanoushadi .
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