| CTRI Number |
CTRI/2025/03/082532 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to evaluate the effect of Sarivadi Lauha in patients of Diabetic Neuropathy |
|
Scientific Title of Study
|
An Open Labelled Randomised Active Controlled Evaluation of Sarivadi Lauha in the Management of Diabetic 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 Patel Denilkumari Nileshkumar |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
OPD NO 116 Department Of Kayachikitsa, Parul Ayurveda Hospital, Parul university,AP Limda, Tal Waghodiya, Vadodara, gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
7046626963 |
| Fax |
|
| Email |
pateldenil111198@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailesh V Deshpande |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
OPD NO 116 Department Of Kayachikitsa, Parul Ayurveda Hospital, Parul university,AP Limda, Tal Waghodiya, Vadodara, gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9763104451 |
| Fax |
|
| Email |
dr.shaileshd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shailesh V Deshpande |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
OPD NO 116 Department Of Kayachikitsa, Parul Ayurveda Hospital, Parul university,AP Limda, Tal Waghodiya, Vadodara, gujarat
GUJARAT
391760
India |
| Phone |
9763104451 |
| Fax |
|
| Email |
dr.shaileshd@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Principal Parul Institute of Ayurved |
| Address |
Faculty of Ayurved, Parul University, AP Limda, Tal Waghodiya, Dis Vadodara 391760, Gujarat, India |
| Type of Sponsor |
Private medical college |
|
|
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 Patel Denilkumari Nileshkumar |
Parul Institute of Ayurved |
OPD NO 116 Department Of Kayachikitsa, Parul Ayurveda Hospital, Parul Institute of Ayurved, Parul University,AP Limda, Tal Waghodiya, Vadodara, gujarat 391760
Vadodara
GUJARAT |
7046626963
pateldenil111198@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul institute of Ayurved- Institutional Ethics 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: PRAMEHAPIDAKA-UPADRAVAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sarivadi Lauha, Reference: Bhaishjya Ratnavali-Prameha Pidika Roga Adhikar Chapter 38/11-12, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Warm Water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Cap pregablin 75mg Methylcobalmin 750 mcg | cap pregabalin 75mg methylcobalmin 750mcg bd afterfood |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1 Known case of Diabetes Mellitus with clinical signs and symptoms of Diabetic neuropathy (Tingling/Pricking/Burning/Numbness)
2 Patient with good to moderate glycemic control
3 Known case of Diabetes mellitus with MNSI Questionnaire score of greater than or equal to 7 and MNSI Examination score of greater than or equal to 2.5.
4 Patient showing altered vibration perception on the basis of biothesiometer.
5 Nerve condution velocity showing the altered velocity of selected nerves in diabetes patients. |
|
| ExclusionCriteria |
| Details |
1. Known case of vitamin B12 deficiency.
2 Patients who present with alcohol abuse.
3 Known cases of autoimmune diseases; including Sjogren’s syndrome, lupus, rheumatoid arthritis, vasculitis and Para neoplastic disorders, and any other SOL-causing nerve dysfunction.
4 Known cases of infection - Leprosy, HIV, STDs, and hepatitis B and C.
5 Known cases of uncontrolled Hypertension.
6 Known cases of Parkinsonism and any other nerve degenerative disorders.7 Patients with known allergy to any drug ingredients of study medicine in the trial group and control group |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of effect of Sarivadi Lauha with Pregabalin+ Methylcobalmine in patient of Diabetic neuropathy on the basis of Biothesiometer and Michigan Neuropathy Screening Instrument |
Baseline, day 15, day 30, day 45, day 60, day 75 and day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare the efficacy of Sarivadi Lauha with Pregabalin+ Methylcobalmine in patients of Diabetic neuropathy on the basis of symptoms observed in patients |
Baseline, Day 15, Day 30, day 45, Day 60, Day
75, Day 90 |
Comparison of effect of Sarivadi Lauha with Pregabalin+ Methylcobalmine in patients of Diabetic
neuropathy on the basis of Nerve Conduction Velocity Test( In 7 patient of each group) |
Baseline, Day 90 |
| Compare the safety of Sarivadi Lauha and Pregabalin+ Methylcobalmine on the basis of adverse events and biochemical parameters –haemogram, renal and hepatic function test, urine routine and microscopic and glycosylated hemoglobin. |
Adverse events on Day 15, Day 30, Day 45, Day 60, Day 75 and Day 90
Biochemical parameters on Baseline, Day 90 |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
31/03/2025 |
| 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) |
Open to Recruitment |
|
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 (DM) is a systemic metabolic disease that causes abnormally high levels of blood sugar. It occurs when the body doesn’t produce enough insulin or the patient has developed insulin resistance. The burden of diabetes is high and increasing globally, and in developing economies like India, mainly fueled by the increasing prevalence of obesity and unhealthy lifestyles. The estimates in 2019 showed that 77 million individuals had diabetes in India, which is expected to rise to over 134 million by 2045. The prevalence of diabetes in India has risen from 7.1% in 2009 to 8.9% in 2019. Currently, 25.2 million adults are estimated to have impaired glucose tolerance, which is estimated to increase to 35.7 million in the year 2045. The complications of diabetes mellitus can be distinguished into acute and chronic complications. The Acute Complication of DM include – Diabetic ketoacidosis and Diabetic coma, Hypoglycemia due to incorrect dose of medication and sudden lifestyle and diet changes, Hyperglycemia The Chronic Complications of DM include – Macroangiopathy: Coronary artery disease, cerebrovascular complication, peripheral vascular disease, Diabetic renovascular disease. Microangiopathy: Diabetic retinopathy, Diabetic nephropathy, Diabetic neuropathy, Diabetic foot. Diabetic neuropathy is a serious diabetes complication that may affect as many as 50% of people with diabetes. However, it can be often prevented or progress can be slowed with consistent blood sugar management and a healthy lifestyle. There was no direct reference available for diabetic neuropathy. As per Ayurvedic principals there is involvement of Vata and Pitta Dosa in DN. Symptoms like Suptata(numbness), Daha(burning sensation) in Hastapad (hands-feet) are described in Purvarupa of Prameha. Daha is also mentioned in Upadravas(complication) of Prameha. Which shows close resemblance with signs and symptoms of DN. Prameha Updrava are – Trushna(Thirst), Atisara(Diarrhea) ,Jwara(Fever) , Daha(Burning Sensation), Durbalata(Weakness), Aruchi(Anorexia), Avipaka(Indigestion). In diabetic neuropathy, micro and macrovascular changes and neuronal ischemia are the important steps in the pathology that can be compared with Raktadusti and Vatadusti which lead to Paddah, Hastpad Suptata. This pathology and symptoms are similar to Vatarakta. In Phalashruti of Sarivadi Lauha it is indicated in Pramehapidika, Vatarakta ,Arsha, Twaggda. Recent researches in Ayurveda have proved efficacy of various herbal and herbomineral drugs in DN. Drugs like Ashwangha, Amlaki, Guduchi, Shilajatu etc were evaluated through preclinical and clinical studies but still effective management is not available for DN. |