| CTRI Number |
CTRI/2025/02/081438 [Registered on: 28/02/2025] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Other (Specify) [therapeutic] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study To Test The Medicine Loha Guugulu (Medicated herbo mineral tablet) Works In Lowering Medovriddi (High Cholestrol And Fat levels in the blood ) |
|
Scientific Title of Study
|
An Interventional Study To Evaluate The Effect Of Loha Guggulu On Lipid Profile In Medovriddi |
| 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 Lakshmi |
| Designation |
PG Scholar |
| Affiliation |
Alvas Ayurveda Medical College and Hospital |
| Address |
Department of PG Studies in Kriya Shareera Alvas Ayurveda Medical College and Hospital Vidyagiri, Moodubidire, Dakshina Kannada district, Karnataka, India
Department of PG Studies in Kriya Shareera Alvas Ayurveda Medical College and Hospital Vidyagiri, Moodubidire, Dakshina Kannada district, Karnataka, India
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
7019535179 |
| Fax |
|
| Email |
gowdalakshmi243@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K N Rajashekhar |
| Designation |
Professor and HOD |
| Affiliation |
Alvas Ayurveda Medical College and Hospital |
| Address |
Department of PG Studies in Kriya Shareera Alvas Ayurveda Medical College and Hospital Vidyagiri, Moodubidire, Dakshina Kannada district, Karnataka, India
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9481511292 |
| Fax |
|
| Email |
drknraamc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lakshmi |
| Designation |
PG Scholar |
| Affiliation |
Alvas Ayurveda Medical College and Hospital |
| Address |
Department of PG Studies in Kriya Shareera Alvas Ayurveda Medical College and Hospital Vidyagiri, Moodubidire, Dakshina Kannada district, Karnataka, India
Department of PG Studies in Kriya Shareera Alvas Ayurveda Medical College and Hospital Vidyagiri, Moodubidire, Dakshina Kannada district, Karnataka, India
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
7019535179 |
| Fax |
|
| Email |
gowdalakshmi243@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department pg studies in kriya shareera, Alvas Ayurveda Medical College, Vidyagiri, Moodbidre, Dakshina Kannada, District, Karnataka |
|
|
Primary Sponsor
|
| Name |
Dr LAKSHMI |
| Address |
PG Scholr Department Of PG Studies In Shreera Kriya, Alvas Ayurveda Medical College, Vidyagiri, Moodbidre, Dakshina Kannada, District, Karnataka |
| Type of Sponsor |
Other [SELF] |
|
|
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 LAKSHMI |
Alvas Ayurveda Medical College and Hospital |
4th Floor, 3rd Hall, Department of kriya shareera, Alvas ayurveda medical college and hospital, vidyagiri, moodbidri
Dakshina Kannada
KARNATAKA |
7019535179
gowdalakshmi243@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Clinical Ethics Committe Alvas Ayurveda Medical College Vidyagiri Moodbidri |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E785||Hyperlipidemia, unspecified. Ayurveda Condition: MEDOVRUDDHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: LOHA GUGGULU , Reference: Yoga ratnakara rasayana adhikara, page number 1250, shloka no. 27 , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Ushnodaka ), Additional Information: nil |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who fulfil daignostic criteria
2. Patient of age between 18 years to 60 years were selected
3. Patients having BMI between 25-35kg/m2
4. Patients willing to participate in the study and ready to sign informed consent form |
|
| ExclusionCriteria |
| Details |
1. Patients having major illnesses like Diabetes mellitus Hypertension Cardiac Problems Thyroid disorders
2. Drug induced Hyperlipidaemia
3. Pregnant and lactating females |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of loha guggulu on lipid profile in medovriddi condition |
30 days of treatment. Follow up on 45th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/03/2025 |
| 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="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
It is a clinical study to evaluate the efficacy of loha guggulu in the form of tablet on lipid profile in medovriddi. medicine will be given for 30days and total 45days of follow up. total 30 subjects will be taken for the study. the study will be conducted in the Alvas ayurveda medical college, vidyagiri, moodbidri |