| CTRI Number |
CTRI/2022/11/047595 [Registered on: 24/11/2022] Trial Registered Prospectively |
| Last Modified On: |
23/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Curative] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Katakakhadiradi kashay Ghan vati and oral Hypoglycemic drug in Prameha(Diabetes mallitus). |
|
Scientific Title of Study
|
A Randomized Standard Controlled Clinical trial to evaluate an add on effect of Katakakhadiradi kashay Ghan vati with oral Hypoglycemic drug in Prameha |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tejal Kiran Suryawanshi |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College Of Ayurved and Research Centre, Nigdi, Pune |
| Address |
PDEAs College Of Ayurved And Research Centre, Third floor, Kayachikitsa department, Sector no.25, Pradhikaran, Nigadi, Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9309941718 |
| Fax |
|
| Email |
tejalsuryawanshi1332@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Medha Joshi |
| Designation |
H.O.D. of Kayachikitsa department |
| Affiliation |
PDEAs College Of Ayurved and Research Centre, Nigdi, Pune |
| Address |
PDEAs College Of Ayurved And Research Centre, Third floor, Kayachikitsa department, Sector no.25, Pradhikaran, Nigadi, Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9881465798 |
| Fax |
|
| Email |
medhamaheshjoshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tejal Kiran Suryawanshi |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College Of Ayurved and Research Centre, Nigdi, Pune |
| Address |
PDEAs College Of Ayurved And Research Centre, Third floor, Kayachikitsa department, Sector no.25, Pradhikaran, Nigadi, Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9309941718 |
| Fax |
|
| Email |
tejalsuryawanshi1332@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Centre Sector no.-25, Nigdi, Pune 411044 |
|
|
Primary Sponsor
|
| Name |
PDEAs College of Ayurved and Research Centre Sector no.-25, Nigdi, Pune |
| Address |
PDEAs College of Ayurved and Research Centre Sector no.-25, Nigdi, Pune 411044 |
| 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 Tejal Kiran Suryawanshi |
Ayurved Rugnalay and Sterling Multispeciality Hospital,Nigdi,Pune |
Vitthal Rukmini Road, Sector no.27, Kayachikitsa O.P.D.no.117, Ground floor, Nigdi Pradhikaran,Pune
Pune
MAHARASHTRA |
9309941718
tejalsuryawanshi1332@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Tb.Metformin | Tb Metformin 500mg Route:Orally,Dosage Form:Tablet, Frequency:BD, Time:Before meal, Duration:15 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Katakakhadiradi Ghan Vati, Reference: Sahasstrayoga, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Koshnajala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Sign and symptoms of Prameha
2.known case of Type-2 DM, NIDDM
3.Patient having HbA1C upto-10
4.Fasting blood sugar upto 250 mg% and post prandial blood sugar upto 350 mg%
5.patient taking Metformin+Glimepride drug since min 6 months |
|
| ExclusionCriteria |
| Details |
1.Juvenile Diabetes and Insulin Dependent Diabetes Mellitus (IDDM).
2.Patients with CKD and AKD.
3.Patients with acute complications Hyperglycemic & hypoglycemic coma,Ketoacidosis and related complication and Infections like gangrene.
4.Patients with chronic diabetic complications Nephropathy, Neuropathy and Retinopathy.
5.Pregnant & lactating women.
6.Patients suffering from all major systemic diseases IHD, TB, CA.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate an efficacy of katakakhadiradi Ghan Vati 500mg twice a day before meal with koshnajala for 3 months as an add on effect to oral hypoglycemic agent in Prameha. |
90 days with follow up on 15th,30th,45th,60th,75th,90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare and study the efficacy of Katakakhadiradi Ghan Vati for 3 months.
2.To compare and study the efficacy of oral hypoglycemic agent for 3 months.
2.To study the adverse effect if any |
90 days with follow up on 15th,30th,45th,60th,75th,90th day |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
28/11/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Prameha which is known to world as Diabetes, is a global health problem and receiving much attention now-a-days. Prameha is can be correlated with classical metabolic disorder. Acharya Charaka has described following Hetus for Prameha like Aasya sukh, Swapna sukh, Dadhini, Gramya-Audak-Anupa-Rasa intake of meat of pet animals . All above hetus cause vitiation of all doshas with increased in Kleda which leads to Dhatwagni mandya. All contains of trial drug has properties like Kledghna, Medodushti Ghan, Rasayan, Kaphghna, Medodhatwagni vardhan properties. Hence this combination possesses all propertioes of potent medicine useful for Prameha chikitsa. To evaluate an add on effect of Katakkhadiradi Kashay Ghan Vati in Prameha with Oral Hypoglycemic Agent this study designed. Therefore, this formulation was choosen for present study. |