| CTRI Number |
CTRI/2026/02/103060 [Registered on: 05/02/2026] Trial Registered Prospectively |
| Last Modified On: |
04/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Ayurvedic medicine in Medoroga.
|
|
Scientific Title of Study
|
Comparative clinical trial to evaluate the efficacy of Patradi Kwatha with Madhu as
an add on therapy for Atorvastatin and Tab. Atorvastatin alone in the management
of Dyslipidemia w.s.r. to 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 Amol Chandrakant Gulve |
| Designation |
PhD Scholar |
| Affiliation |
Shree Saptashrungi Ayurved College and Hospital |
| Address |
Kamalnagar Hirawadi Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9423119677 |
| Fax |
|
| Email |
amolgulve43@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amol Chandrakant Gulve |
| Designation |
PhD Scholar |
| Affiliation |
Shree Saptashrungi Ayurved College and Hospital |
| Address |
Kamalnagar Hirawadi Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9423119677 |
| Fax |
|
| Email |
amolgulve43@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Somadtta Bhaskarrao Kulkarni |
| Designation |
Professor |
| Affiliation |
Shree Saptashrungi Ayurved College and Hospital |
| Address |
OPD of KJayachikitsa, Shree Saptashrungi Ayurved College and Hospital, Kamalnagar, Hirawadi, Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9860268117 |
| Fax |
|
| Email |
somdattak85@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kayachikitsa, Shree Saptashrungi Ayurved College and Hospital,Kamalnagar,Hirawadi, Nashik |
|
|
Primary Sponsor
|
| Name |
Amol Chandrakant Gulve |
| Address |
Shree Saptashrungi Ayurved College and Hospital, kamal nagar, Hirawadi, Nashik |
| 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 |
| Amol Chandrakant Gulve |
Shree Saptashrungi Ayurved College and Hospital |
Shree Saptashrungi Ayurved College and Hospital,Kamalnagar, Hirawadi, Nashik
Nashik
MAHARASHTRA |
9423119677
amolgulve43@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe, Shree Saptashrungi ayurved College and Hospital, Nashike |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: MEDOROGAH, (2) ICD-10 Condition:E668||Other obesity. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Patradi Kwatha, Reference: Ras ratnasamucchaya, chapter- 25th , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Tab. Atorvastatin | Tab. Atorvastatin 20mg, frequency-OD, Duration-90 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Day(s) |
| Age To |
60.00 Day(s) |
| Gender |
Both |
| Details |
1) Within one year of recently diagnosed patients of Medoroga (Dyslipidemia) on the
basis of Lipid Profiles.
2) Patients having Serum Cholesterol level 240mg/dl to 350mg/dl. (S. Cholesterol =
200 to 239 mg/dl.)
3) Serum Triglyceride levels 150mg/dl to 250mg/dl ( Sr.Triglyceride = less than 150
mg/dl)
4) LDL level 100mg/dl to 150mg/dl (normal range= less than 100mg/dl)
5) HDL 20mg/dl to 30mg/dl (normal value above 40mg/dl)
6) Adult age between 20-60 years.
7) Patients having clinical symptoms of Medodushti among followingKshudra Shwasa (Breathlessness on exertion)
Sarvakarmasu Ashaktata (difficulty in normal daily activity)
Swedadhikya (Excessive sweating)
Daurbalya (Weakness) |
|
| ExclusionCriteria |
| Details |
1) Thyroid Disorder, genetic disorders, autoimmune disorders.
2) Patients suffering from chronic Anaemia, Renal insufficiency.
3) Co morbid patients like HTN, DM, Insulin dependent Diabetes mellitus, IHD,
Angina Pectoris, MI.
4) Patients receiving Anti retro Viral Therapy.
5) Pregnancy and Lactation.
6) Age less than 20 years and more than 60 years. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To decrease the Cholesterol, Triglyceride, LDL level After oral Administration oF Patradi Kwatha for 90 Days. |
0 day(1st visit),31th day(2nd visit),61th day(3rd visit),91th day(4th visit) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Decrease the symptoms of Medoroga with special reference to Dyslipidemia. |
0 day(1st visit),31th day(2nd visit),61th day(3rd visit),91th day(4th visit) |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
N/A |
|
Date of First Enrollment (India)
|
18/02/2026 |
| 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="2"
Months="0"
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
|
In the conventional part usually the treatment is started by administering drug with Hypolipidemic agents includes bile acid sequestrates, Niacin, Fibric acid and HMG-COA reductase inhibiters. Standard treatment with statins groups (Atorvastatin) help to normalized the biochemical markers only i.e. Lipoproteins. But it has very low effect on the symptoms like snigdha-angata, shramahani, daurbalyata. Due to such unsatisfactory results on the symptomatic relief it has prompted the question of whether the Atorvastatin treatment is sufficient for all Patients or whether alternative therapies could be adopted. Being a part of Ayurveda medicine system it is necessary to search out the effective and safe medicinal therapy which can be used as an add on therapy for Atorvastatin to help the patients to get symptomatic relief. Dyslipidemia/ Medorog is Kapha dushti pradhan and santarpanjanya vyadhi. All these drugs in patradi kwatha may help to normalize the vitiated Kapha –Vaat Dosha with their Ushna virya and Katu Vipak. With the help of ruksha, laghu, vishad, lekhanam guna of Madhu it balances Kapha and pitta dosha. Antioxidant, anti-inflammatory, antidiabetic, antimicrobial, anticancer, lipid-lowering, and cardiovascular-disease lowering activity of Haridra and tejapatra has studied in clinical trials. When this Patradi Kwatha along with Madhu will be used as add on therapy for Atorvastatin, it will be beneficial for reduction in symptoms, may help to minimize side effects of Atorvastatin with its dose and duration reduction. It may provide the good adjuvant treatment option for the unsatisfactory treatment with liposuction alone in dyslipidemia. So the Patradi Kwatha along with Madhu is selected for present study |