| CTRI Number |
CTRI/2023/11/059698 [Registered on: 09/11/2023] Trial Registered Prospectively |
| Last Modified On: |
07/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to determine the efficacy of amritadya guggulu and haritaki churna in medo roga |
|
Scientific Title of Study
|
“A clinical study to determine the efficacy of Amritadya Guggulu and Haritaki Churna in the management of Medoroga w.s.r 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 |
Prof Anjana Mishra |
| Designation |
Head of the Department |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital |
| Address |
Room no 317 of Kayachikitsa Department in Hospital building of Rajiv Gandhi Govt Post Graduate Ayurvedic College and hospital Paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418312324 |
| Fax |
|
| Email |
dranjana269@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geetika Dharmani |
| Designation |
Ayurvedic medical officer |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and hospital Paprola |
| Address |
Room no 317 of Kayachikitsa Department in Hospital building of Rajiv Gandhi Govt Post Graduate Ayurvedic College and hospital Paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7018817072 |
| Fax |
|
| Email |
Dr.geeti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Thakur |
| Designation |
P. G. Scholar |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and hospital, Paprola |
| Address |
Room no 317 of Kayachikitsa Department in Hospital building of Rajiv Gandhi Govt Post Graduate Ayurvedic College and hospital Paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9816015670 |
| Fax |
|
| Email |
drneha547@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Pharmacy, Rajiv Gandhi Govt Post Graduate Ayurvedic College and hospital Paprola |
|
|
Primary Sponsor
|
| Name |
Prof Anjana Mishra |
| Address |
Room no 317 of Kayachikitsa Department in Hospital building of Rajiv Gandhi Govt Post Graduate Ayurvedic College and hospital Paprola |
| 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 |
| Prof Anjana Mishra |
RAJIV GANDHI GOVT POST GRADUATE AYUREDIC COLLEGE & HOSPITAL PAPROLA DISTT KANGRA (HP) |
Room no 317 of Kayachikitsa Department in Hospital building
Kangra
HIMACHAL PRADESH |
9418312324
dranjana269@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Human) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E782||Mixed hyperlipidemia. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Amritadya Guggulu , Reference: Chakradutt, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Amritadya Guggulu , Reference: Chakradutt, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information: - | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Haritaki churna, Reference: Charak Sutra sathan 23/9, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Luke warm water ), Additional Information: - | | 4 | Comparator Arm (Non Ayurveda) | | - | Tab Atorvastatin | 10 mg once a day at bed time for 8 weeks |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients who present with signs and symptoms of medoroga
Patients having serum cholesterol 200 to 300mg/dl, s. Triglycerides 150 to 350 mg/dl, S. LDL 100 to 200 mg/dl, S. VLDL 30 TO 100 mg/dl and S. HDL 20 to 40 mg/dl |
|
| ExclusionCriteria |
| Details |
Patients having past history of Myocardial infarction, unstable angina, congestive cardiac failure and cerebro vascular accident.
Patients having past illness like carcinoma, renal and liver disorders
Pregnant females and lactating mother |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A clinical study to determine the efficacy of Amritadya Guggulu & Haritaki Churna in the management of medoroga w.s.r to Dyslipidemia |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the clinical safety & untoward effects of Amritadya Guggulu & Haritaki Churna in patients of Medoroga w.s.r Dyslipidemia |
8 weeks |
|
|
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 |
|
Date of First Enrollment (India)
|
20/11/2023 |
| 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="2"
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
|
I plan to publish my work after completing the research trial as soon as possible. A minimum number of 30 patients will be selected from OPD and IPD of Kayachikitsa Department in Rajiv Gandhi Govt Post Graduate Ayurvedic College and hospital Paprola Distt Kangra. A total number of 30 patients will be divided into 2 groups containing 15 patients each. One group will be managed with tab atorvastatin 10 mg once a day. The other group will be managed with haritaki churna for koshtha shudhi followed by Amritadya guggulu 500 mg Twice daily for a period of 8 weeks. |