| CTRI Number |
CTRI/2024/04/066337 [Registered on: 25/04/2024] Trial Registered Prospectively |
| Last Modified On: |
23/11/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical study to compare the effects of Ayurvedic drug Guggulu Rasayan over another Ayurvedic drug Vidangadi Loha with Honey water in Dyslipidemia (Medoroga) |
|
Scientific Title of Study
|
A Randomized comparative Clinical Study to evaluate the efficacy of Guggulu Rasayana over Vidangadi Loha with Madhudaka in the Management of Medoroga with special reference to Dyslipidemia |
| 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 Namita Minajagi |
| Designation |
Assistant Professor |
| Affiliation |
BVVS Ayurved Medical College and Hospital, Bagalkot |
| Address |
BVVS Ayurveda Medical College and Hospital,
Department of Kayachikitsa
Ward No-10, Bagalkot
BVVS Ayurveda Medical College and Hospital, Ward No-10, Bagalkote, Karnataka-587101
Bagalkot
KARNATAKA
587101
India |
| Phone |
9739085906 |
| Fax |
|
| Email |
minajiginamita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namita Minajagi |
| Designation |
Assistant Professor |
| Affiliation |
BVVS Ayurved Medical College and Hospital, Bagalkot |
| Address |
BVVS Ayurveda Medical College and Hospital,
Department of Kayachikitsa
Ward No-10, Bagalkot
BVVS Ayurveda Medical College and Hospital,
Department of Kayachikitsa
Ward No-10, Bagalkot
Bagalkot
KARNATAKA
587101
India |
| Phone |
9739085906 |
| Fax |
|
| Email |
minajiginamita@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namita Minajagi |
| Designation |
Assistant Professor |
| Affiliation |
BVVS Ayurved Medical College and Hospital, Bagalkot |
| Address |
BVVS Ayurveda Medical College and Hospital,
Department of Kayachikitsa
Ward No-10, Bagalkot
BVVS Ayurveda Medical College and Hospital, Ward No-10, Bagalkote, Karnataka-587101
Bagalkot
KARNATAKA
587101
India |
| Phone |
9739085906 |
| Fax |
|
| Email |
minajiginamita@gmail.com |
|
|
Source of Monetary or Material Support
|
| BVVS Ayurvedic Medical College and Hospital Bagalkot |
|
|
Primary Sponsor
|
| Name |
BVVS Ayurvedic Medical College and Hospital Bagalkot |
| Address |
BVVS Ayurveda Medical College and Hospital,
Department of Kayachikitsa
Ward No-10, Bagalkot |
| 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 Namita Minajagi |
BVVS Ayurvedic Hospital Bagalkot |
BVVS Ayurved Medical College and Hospital,
Department of Kayachikitsa
Bagalkot
KARNATAKA |
9739085906
minajiginamita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BVVS Ayurved Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E785||Hyperlipidemia, unspecified. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Guggulu Rasayan, Reference: Rasaratna Samuchaya, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -Madhudaka), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vidangadi Loha, Reference: Bhaishajya ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -Madhudaka), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Having clinical features of Dyslipidemia and Medoroga
2. Serum lipid levels ranging
Serum Cholesterol (201mg/dl or more)
Serum Triglycerides (161mg/dl or more)
Serum HDL (below 41mg/dl
Serum LDL (131mg/dl or more)
Serum VLDL (41mg/dl or more)
All or any of these.
3. Patients between the ages from 20-60 years of either sex
|
|
| ExclusionCriteria |
| Details |
1. Patients having Cardiac problem
2. Patients suffering with serious metabolic disorders like Diabetes Mellitus and HTN.
3. Pregnancy and Lactating Women.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the parameters of Lipid profile |
After 60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prevention of Lifestyle disorders like Obeysity, Atherosclerosis, Cardiac Attacks |
After 120 days |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
02/05/2024 |
| 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="3"
Months="0"
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
|
Primary purpose of the protocol is to analyse the effectiveness of ayurvedic medicines on Dyslipidemia which is the basic cause for many Lifestyle disorders. As a research candidate I am trying to compare the efficacy of two Ayurvedic drugs. Expecting that the intervention drug gives more effective result than the standard group |