| CTRI Number |
CTRI/2024/03/064201 [Registered on: 15/03/2024] Trial Registered Prospectively |
| Last Modified On: |
15/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Clinical study of dashamoolaadi ghanavati with Panchaprasritik vasti in the management of diabetic neuropathy |
|
Scientific Title of Study
|
A Comparative Clinical evaluation of Dashamoolaadi ghanavati and panchatikta panchaprasritik Vasti in the management of madhumeha janya nadipratan shotha with special reference to 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 Rukhsar parveen |
| Designation |
M.D(Ay)Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of kayachikitsa faculty of ayurveda IMS BHU Varanasi
Department of kayachikitsa faculty of ayurveda IMS BHU Varanasi 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7275776962 |
| Fax |
|
| Email |
rukhsarbhu94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof OP Singh |
| Designation |
Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of kayachikitsa Faculty of ayurveda IMS BHU Varanasi
Department of kayachikitsa faculty of ayurveda IMS BHU Varanasi 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415818732 |
| Fax |
|
| Email |
singhopbhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof OP Singh |
| Designation |
Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of kayachikitsa Faculty of ayurveda IMS BHU Varanasi
Department of kayachikitsa faculty of ayurveda IMS BHU 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415818732 |
| Fax |
|
| Email |
singhopbhu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir sundarlal Hospital Institute of Medical sciences varanasi 221005 |
|
|
Primary Sponsor
|
| Name |
Department of kayachikitsa Faculty of ayurveda IMS BHU |
| Address |
Department of kayachikitsa , faculty of ayurveda,INSTITUTE OF MEDICAL SCIENCES BHU VARANASI |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rukhsar parveen |
Sir Sunderlal Hospital BHU |
Department of kayachikitsa and Department of Neurology IMS BHU
Varanasi
UTTAR PRADESH |
7275776962
rukhsarbhu94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethicscommittee IMS ,BHU |
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, (2) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications, (3) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications, (4) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications, (5) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dashamoolaadi ghanavati and panchatikta Panchaprasritik vasti and standard treatment |
Dashamoolaadi ghanavati 500mg , freq- BD route- oral,and panchatikta Panchaprasritik vasti 500 ml ,dosage form- enema, route- per rectum freq- once in a day for 7 days in a month for 3 month+ standard treatment (pregabalin dosage form -capsule, dose-75 mg freq-BD, ROUTE- ORAL or duloxetine 60 mg freq- BD route-oral, dosage form- capsule |
| Intervention |
Dashamoolaadi ghanavati standard treatment |
Group 1/Intervention 1 -treated with dashamoolaadi ghanavati 500 mg frequency- BD,route-oral (ref Chakradutta Jhinjhini vata chikitsa 22/64) + Standard treatment ( pregabalin 75mg route-oral, freq-BD, Dosage form- Capsule or duloxetine 60mg route-oral, freq-BD, dosage form -capsule
|
| Intervention |
panchatikta Panchaprasritik vasti and standard treatment |
Procedure Reference :(Charak Siddhi sthana 8/8)Panchatikta Panchaprasritik vasti 500ml Route-per rectum frequency - once in a day, Niruha vasti will be done for 7 days in every month + standard treatment (pregabalin 75mg frequency -BD route- oral dosage form- capsule,
taken after food or Duloxetine-60 mg , frequency-BD, Route -oral, dosage form- capsule, after food |
| Comparator Agent |
Standard group |
Pregabalin dose-75mg, dosage form- capsule, route-oral, freq-BD,OR duloxetine 60mg BD ROUTE -Oral, dosage form-capsule,after food |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Diagonosed case of diabetic neuropathy
Diagonosed cases of Diabetes Mellitus type2.
Patient willing to participate in the above trial and giving informed consent. |
|
| ExclusionCriteria |
| Details |
Cases with the co occurrence of neuropathy without diabetes mellitus
Pregnant and lactating women
Patient with low level of vitamin B12
Patient who took other medicines
Patient with diabetic nephropathy and retinopathy |
|
|
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
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To evaluate the clinical efficacy of Dashamoolaadi Ghanavati and Panchatikta PanchaPrasritik Vasti in the cases of Diabetic Neuropathy (DN).
|
the trial drug will be given for 3 months along with 7 days enema with 3 follow up in each month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
2) To study the conventional concepts of diabetic Neuropathy (DN) & its possible correlation in Ayurveda viz. Madhumeha janya nadi pratan shotha
1) Objective assesment by,a)Nerve conduction study
b) blood glucose fasting ,Post prandial , HBa1c |
3 months
treatment course will be given for 3 months & 3 follow ups before treatment after 45 days & after 3 months will be recorded |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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 2 |
|
Date of First Enrollment (India)
|
25/03/2024 |
| 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="3"
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
|
Diabetes mellitus is a multifactorial metabolic disorder. It is one of the most important medical problems of today. Diabetes as such not kill the patient but its complication are responsible for mortality and morbidity . Diabetic Neuropathy is one of the commonest problem associated with diabetes mellitus. Individuals with diabetes may develop acute or sub acute painful polyneuropathy, proximal motor neuropathyi.e loss of senses or feeling of pain is first felt in the extremities , especially toes, feets, hands. It may occur in the other part of body. In ayurvedic literature Diabetes Mellitus i.e. Madhumeha is mentioned as a maharoga because it affects all parts of body and every cell of human physiology. Diabetic neuropathy is not directly mentioned in ayurvedic texts but the lakshanas of diabetic neuropathy sensation i.e burning sensation(daha),tingling sensation ,numbness(susuptta), are explain under poorvaroopa and upadrava of prameha. Diabetic Neuropathy can be correlated to madhumeha janya nadi pratan sotha because manifestation of vata symptoms i.e gatrasusuptta(numbness), toda(excrutiating pain) and hasta pada tala daha(burning sensation of hands,feet and soles) symptoms of pitta. Hence drugs pacifying vata and pitta doshas are useful in the treatment of Diabetic Peripheral Neuropathy. In ayurveda biopurifactory methods(samshodhana) ,and palliative treatment (samshamana) are the modes of treatment indicated for the complete eradication of doshas and eliminate the disease. |