| CTRI Number |
CTRI/2024/12/078111 [Registered on: 16/12/2024] Trial Registered Prospectively |
| Last Modified On: |
14/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To compare between Lekhan Basti with Ushkadi Gana and Lekhan Basti with Triphala Gana as Prakshepa against Standard Control in Management of Dyslipidemia Medoroga |
|
Scientific Title of Study
|
evaluation of comparative efficacy of lekhan basti with ushkadi gana versus lekhan basti with triphala gana as against standard control in management of dyslipidemia (medoroga) |
| 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 Samiksha Someshwar Satone |
| Designation |
Pg Scholar |
| Affiliation |
Mahatma Gandhi Ayurvedic College Hospital and Research Centre |
| Address |
Room number 40 Department of Panchakarma Mahatma Gandhi
Ayurved College Hospital and research center salod
Wardha
MAHARASHTRA
4420001
India |
| Phone |
9130921766 |
| Fax |
|
| Email |
satonesamiksha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Samiksha Someshwar Satone |
| Designation |
Pg Scholar |
| Affiliation |
Mahatma Gandhi Ayurvedic College Hospital and Research Centre |
| Address |
Room number 40 Department of Panchakarma Mahatma Gandhi
Ayurved College Hospital and research center salod
MAHARASHTRA
4420001
India |
| Phone |
9130921766 |
| Fax |
|
| Email |
satonesamiksha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shweta Parwe |
| Designation |
HOD Professor |
| Affiliation |
Mahatma Gandhi Ayurvedic College Hospital and Research Centre |
| Address |
Room number 40 Department of Panchakarma Mahatma Gandhi
Ayurved College Hospital and research center salod
Wardha
MAHARASHTRA
442001
India |
| Phone |
9511659185 |
| Fax |
|
| Email |
shweta.parwe@dmiher.edu.in |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod Wardha Maharashtra India 442001 |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Ayurved College Hospital and Research Centre |
| Address |
Room no 40 Department of Panchakarma Mahatma Gandhi Ayurved
College Hospital and Research Centre Hirapur Salod Mahatma
Gandhi Ayurved College Hospital and Research Centre
Wardha
MAHARASHTRA
442001
India
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Samiksha Satone |
Mahatma Gandhi Ayurved College Hospital and Research Centre |
Room no 40
Department of Panchakarma Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur
Wardha
MAHARASHTRA |
9130921766
satonesamiksha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Ayurved College Hospital and Research 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 (Non Ayurveda) | | - | Tab. Atorvastatin | Tablet Atorvastatin 10 mg 1 tab Once in a Day after food for 48 days. | | 2 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Sushrut Chikitsasthana, Procedure details: Lekhana basti will be prepared with triphala gana as prakshepa dravya 150 gm & will be administered to the patient on empty stomach once daily & anuvasana basti will also be administred in kaal yoga pattern )
)
(1) Medicine Name: Triphala Gana, Reference: Sushrut Chikitsasthana, Route: Rectal, Dosage Form: Not Applicable, Dose: 960(ml), Frequency: od, Duration: 16 Days | | 3 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Sushrut Chikitsasthana, Procedure details: Lekhan basti will be prepared with ushkaadi gana as prakshepa dravya 150 gm & will be administered to the patient on an empty stomach once daily & anuvasana basti will also be administered in kaal yoga pattern.)
(1) Medicine Name: ushakadi gana, Reference: Sushrut chikitsasthana, Route: Rectal, Dosage Form: Not Applicable, Dose: 960(ml), Frequency: od, Duration: 16 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are willing to give written informed consent
Patients aged between 20 to 60 years
Newly diagnosed dyslipidemia patient with
Serum cholesterol 200 mg per dl 239 mg per dl
Serum triglycerides 150 mg per dl 199 mg per dl
Serum HDL more than 60 mg per dl
Serum LDL more than 159 mg per dl
Serum VLDL 30 mg per dl
Patient fit for Basti
Patient BMI between 24 point 9 kg per m2 to 30 kg per m2
Patient with controlled hypertension
Patient with controlled type II DM fasting 100 to 130 mg per dl PP 140 to 180 mg per dl
|
|
| ExclusionCriteria |
| Details |
Patient with known cases of Cancer tuberculosis cardiac disorders thyroid disorders uncontrolled hypertension hemorrhoids fissures any other rectal disease etc
Patients Ayogya for Niruha Basti were excluded from the study
Patient with uncontrolled type 2 diabetes
Pregnant and lactating women
Patients with addictions like drugs or drinks smoking and alcohol
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction in triglyceride and Total Cholesterol |
at baseline 0 16day 48day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison between the reduction in Triglyceride & Cholesterol |
at baseline 0 2weeks 6weeks 4 days |
|
|
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 3 |
|
Date of First Enrollment (India)
|
25/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/12/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
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
|
The volunteers will be informed about the study protocol. Willing participants will be randomly selected as per computer generated table. Clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC, MGACHRC, Salod (H) Wardha and CTRI registration will be done. After selection, each participant will be tested individually and selected according to selection criteria. They are divided into two groups the trial is a Randomized open labelled Standard controlled equivalence clinical trial. It will include a 48 days treatment period and at Day follow up period 0th, 16th and 48th day. |