| CTRI Number |
CTRI/2024/06/069147 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
13/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the efficacy of guduchayadi yog in the management of dislipidemia |
|
Scientific Title of Study
|
Pharmacognostical and Pharmacotherapeutical evaluation of
Guduchayadi yog in the management of Medoroga (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 Mukesh Jangir |
| Designation |
MD Scholar |
| Affiliation |
Post Graduate Institute Of Ayurveda DSRRAU JODHPUR |
| Address |
Department of Dravyaguna Post Graduate institute of Ayurveda
DSSRAU Naguar road karwar Jodhpur
RAJASTHAN
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9413314953 |
| Fax |
|
| Email |
dr.mukesh.jangir@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukesh Jangir |
| Designation |
MD Scholar |
| Affiliation |
Post Graduate Institute Of Ayurveda DSRRAU JODHPUR |
| Address |
Department of Dravyaguna Post Graduate institute of Ayurveda
DSSRAU Naguar road karwar Jodhpur
RAJASTHAN
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9413314953 |
| Fax |
|
| Email |
dr.mukesh.jangir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandan Singh |
| Designation |
Professor & Hod |
| Affiliation |
Post Graduate Institute Of Ayurveda DSRRAU JODHPUR |
| Address |
Department of Dravyaguna Post Graduate institute of Ayurveda
DSSRAU Naguar road karwar Jodhpur
RAJASTHAN
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9950156020 |
| Fax |
|
| Email |
chandan_singh4@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurveda DSRRAU Jodhpur Rajasthan India 342037 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurveda DSRRAU Jodhpur |
| Address |
Department of Dravyaguna , Post Graduate institute of Ayurveda ,
DSSRAU JODHPUR naguar road Karwar, Rajasthan India 342037 |
| Type of Sponsor |
Government 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 Chandan Singh |
Sanjeevani Hospital Post Graduate Institute Of Ayurveda DSRRAU Jodhpur |
Department Of Dravayguna Post Graduate Institute of Ayurveda DSRRAU Jodhpur
Jodhpur
RAJASTHAN |
9950156020
Chandan_singh4@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University, Jodhpur Post Graduate Institute of Ayurveda Institutional Ethics Committee |
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: Guduchayadi yog, Reference: Yogaratnakar, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -honey), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients of either sex from age 25 to 60 years. 2) Patients will be diagnosed on the basis of Dyslipidemia index. Any one or more of the following criteria will be selected. • Elevated levels of serum cholesterol (201 mg/dl or more)  Ratio of total cholesterol to HDL is should be grater than 4.5 • Elevated serum triglycerides (S. TGs) (151 mg/dl to more) • Elevated serum low density lipoprotein (S. LDL) (131 mg/dl or more) |
|
| ExclusionCriteria |
| Details |
1. Age below 25 years and above 60 years of either sex. 2. Dyslipidemia associated with hyperthyroidism, Hypertension, Diabetes Mellitus or Cushing syndrome 3. Any concomitant serious disorder of the liver, kidney, heart, lungs or other organs. 4. Person undergoing treatment for any other serious illness. 5. Pregnancy and lactation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Lipid profile, CBC, Blood sugar |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of trial drug in
management of Dyslipidemia
Pharmacognostical study and Phytochemical analysis of Guduchi (Tinospora cordifolia ), and Nagarmotha (Cyperus rotundas ) to determine the family characters and different constituents of plants. |
45 days |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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="6"
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
|
This is an open label single arm trial to evaluate the efficacy of Guduchayadi Yog in management of Dyslipidemia . In this study 6 gm of Guduchayadi yog Churna will be given to patients twice a day with honey for 45 days. 1. Follow up period will be every 15th day for 45 days. 2. Improvement and other effects will be noted. 3. Laboratory investigations will be repeated for the assessment (0-45-90th days). |