| CTRI Number |
CTRI/2025/04/084847 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
03/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
effect of Pippali and Guduchi on participants suffering from Hyperlipidemia |
|
Scientific Title of Study
|
A comparative clinical study of Pippali (Piper longum Linn) and Guduchi (Tinospora cordifolia Willd) on Medoroga WSR to Hyperlipidemia |
| 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 Preeti Solanki |
| Designation |
PG Scholar |
| Affiliation |
Govt Auto Dhanwantri Ayurved Medical College |
| Address |
Dept of Dravyaguna Govt Auto Dhanwantri Ayurved Medical College Mangalnath Road Ujjain
Ujjain
MADHYA PRADESH
456001
India |
| Phone |
9669557962 |
| Fax |
|
| Email |
preetifly.solanki@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shiromani Mishra |
| Designation |
Reader |
| Affiliation |
Govt Auto Dhanwantri Ayurved Medical College |
| Address |
Dept of Dravyaguna Govt Auto Dhanwantri Ayurved Medical College Mangalnath Road Ujjain
Ujjain
MADHYA PRADESH
456001
India |
| Phone |
9893158853 |
| Fax |
|
| Email |
shiromishra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shiromani Mishra |
| Designation |
Reader |
| Affiliation |
Govt Auto Dhanwantri Ayurved Medical College |
| Address |
Dept of Dravyaguna Govt Auto Dhanwantri Ayurved Medical College Mangalnath Road Ujjain
Ujjain
MADHYA PRADESH
456001
India |
| Phone |
9893158853 |
| Fax |
|
| Email |
shiromishra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt Auto Dhanwantri Ayurved Medical College Ujjain Madhya Pradesh India 456001 |
|
|
Primary Sponsor
|
| Name |
Govt Auto Dhanwantri Ayurved Medical College |
| Address |
Govt Auto Dhanwantri Ayurved Medical College Mangalnath Road Ujjain Madhya Pradesh India 456001 |
| 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 Preeti Solanki |
Govt Auto Dhanwantri Ayurved Medical College |
Dept of Dravyaguna Govt Auto Dhanwantri Ayurved Medical College Mangalnath Road Ujjain
Ujjain
MADHYA PRADESH |
9669557962
preetifly.solanki@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Guduchi, Reference: Astanghridya Sutrasthana 14/22, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: pippali, Reference: Bhavprakash Nighantu Haritkyadivarga 1/57, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of hyperlipidemia on the basis of investigation and patients with clinical signs and symptoms of Medoroga as mentioned in Ayurveda and modern literature |
|
| ExclusionCriteria |
| Details |
Patients suffering from type 1 Diabetes mellitus Tuberculosis Renal cirrhosis or carcinoma
Pregnant women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in sign and symptoms of disease |
Change in sign and symptoms of disease at 7th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| assessment of changes in clinical parameter after 15 days |
1st follow up at 15th day
2nd follow up at 30th day
after treatment 45th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
30/04/2025 |
| 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="1"
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
|
This is randomized interventional " A Comparative clinical study of Pippali Churna (Piper longum Linn.) and Guduchi churna (Tinospora cordifolia Willd.) on Medoroga W.S.R. to Hyperlipidemia". Patients will be selected randomly for the study and will be divided into 2 groups. Each group will contain 30 patients. For the present study patients of either sex having the age group of 20 to 65 years who will present with complains of sign and symptoms of Medoroga w.s.r. to Hyperlipidemia will be selected irrespective of their religion and occupation etc. from the OPD of Government Dhanwantri Ayurveda medical College & Hospital Ujjain M.P. |