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CTRI Number  CTRI/2024/10/075360 [Registered on: 16/10/2024] Trial Registered Prospectively
Last Modified On: 15/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Matra Vasti]  
Study Design  Single Arm Study 
Public Title of Study   Effect of the Vachaharidradigana kwatha(oral) and Triphaladya taila Matravasti in the management of Medoroga (Hyperlipidemia) 
Scientific Title of Study   Evaluation of the Clinical Efficacy of Vachaharidradi Gana Kwatha Oral and Triphaladya Taila Matravasti in the Management of Medoroga w s r 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 Rena Ravali 
Designation  Post Graduate in Kaya Chikitsa 
Affiliation  Dr BRKR Govt Ayurvedic Medical College & Hospital 
Address  4/41/A Erraballe, Hanamkonda
Room no.1, Unit no.1, Dr BRKR Govt Ayurvedic Medical College and Hospital, Erragadda, Hyderabad - 500038
Hyderabad
TELANGANA
505471
India 
Phone  9573958108  
Fax    
Email  ravalirena97@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Neredu Uma Srinivas Rao 
Designation  Professor, MD Ayurveda, (Ph.D), Department of Kaya Chikitsa 
Affiliation  Dr BRKR Govt Ayurvedic Medical College &Hospital 
Address  Department of Kaya Chikitsa, Room no.1, Unit no.1, Dr BRKR Govt Ayurvedic Medical College and Hospital, Erragadda

Hyderabad
TELANGANA
500038
India 
Phone  9246346346  
Fax    
Email  dr.nusrao@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Neredu Uma Srinivas Rao 
Designation  Professor, MD Ayurveda, (Ph.D), Department of Kaya Chikitsa 
Affiliation  Dr BRKR Govt Ayurvedic Medical College &Hospital 
Address  Department of Kaya Chikitsa,Room no.1, Unit no.1, Dr BRKR Govt Ayurvedic Medical College and Hospital, Erragadda

Hyderabad
TELANGANA
500038
India 
Phone  9246346346  
Fax    
Email  dr.nusrao@gmail.com  
 
Source of Monetary or Material Support  
Dr BRKR Govt Ayurvedic Medical College and Hospital, Erragadda, Hyderabad, 500038, Telangana, India 
 
Primary Sponsor  
Name  Dr Rena Ravali 
Address  Department of Kaya Chikitsa, Dr. BRKR Govt. Ayurvedic Medical and Hospital, Erragadda, Hyderabad, 500038, Telangana, India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rena Ravali  Dr BRKR Government Ayurvedic Medical College and Hospital  Department of Kaya Chikitsa, Room No.1, Unit No.1, Erragadda, 500038
Hyderabad
TELANGANA 		 9573958108

ravalirena97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee of Dr. BRKR Govt Ayurvedic Medical College and Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E782||Mixed hyperlipidemia. Ayurveda Condition: MEDOROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: Bhaishajya Ratnavali, Medoroga Chikitsa prakarana, Chapter 39, Shloka47-49 and Chakradatta, Sthoulya chikitsa, Chapter 36, Shloka 30-32, Procedure details: Matravasti with Triphaladya Taila administered for first 7 days of every month, for 3 consecutive months. Dose of tail- 60 ml per day Route of drug administration- Anorectal)
(1) Medicine Name: Triphaladya taila, Reference: Matravasti with Triphaladya Taila administered for first 7 days of every month, for 3 consecutive months. Dose of tail- 60 ml per day Route of drug administration- Anorectal ), Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 21 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients having Prathyatma Lakshanas of Medoroga (Kshudra swasa, Trishna, Krathanam, Atinidra, Swedadikya).
2.Ptients having alteration in one or more component of the lipid profile.
3. Triglycerides 150-450mg/dl, Total Cholesterol 200-399 mg/dl, low density lipoprotein 100-190mg/dl
4. Patients indicted for Vasti karma
5. Patients who are willing to participate in the study and agree for consent sign  
 
ExclusionCriteria 
Details  1.Patients with uncontrolled Non insulin dependent Diabetes Mellitus, Hypertension and Hypothyroidism.
2.Patients having Congenital hyperlipidemia ( like xanthomas ) ,Systemic disorders, Chronic kidney diseases, Drug induced hyperlipidemia eg; glucocorticoids etc. and who is suffering from HIV, Carcinoma.
3.Known gene mutations are excluded.
4.Pregnant women and lactating mothers.
5.Patients contraindicated for vasti karma.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To reduce the symptoms of Hyperlipidemia  90 days 
 
Secondary Outcome  
Outcome  TimePoints 
To Reduce raised Total cholesterols, triglycerides, LDL Counts  90 days 
 
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 3 
Date of First Enrollment (India)   26/10/2024 
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="1"
Months="6"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ravalirena97@gmail.com].

  6. For how long will this data be available start date provided 10-10-2024 and end date provided 10-04-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
      Medoroga is a condition in which there is an excessive production of medodhatu in the body. Accumulation of medodhatu in different parts of the body causes blockage of srotas which ultimately leads to poor nourishment of other dhatus. Kaphavardhaka ahara and vihara are the two main causes of Medoroga. Symptoms like KshudraSwasa, Trshna,  Moha, Atinidra, Krathana, Sadana, Kshud, Atisweda, Dourgandhya, Alpa Prana and Alpa Maithuna are seen in Medoroga. In modern times, the way of life has changed drastically to quick nourishments and inactive tendencies throughout the world. Because of these factors, accumulation of medodhatu happens immensely. Hyperlipoproteinemia or Hyperlipidemia involves abnormally elevated levels of any or all lipids and / or lipoproteins in the blood. It is the most common form of Dyslipidemia. Hyperlipidemia is divided into Primary and Secondary subtypes. Primary Hyperlipidemia is usually due to genetic causes ( such as a mutation in receptor protein), while secondary Hyperlipidemia arises due to other underlying causes such as Diabetes, Thyroid, Renal disorders, Liver disorders and  Cushing’s syndrome. Hyperlipidemia is one such condition that has been described as a possible risk factor for a wide range of diseases including Cardio vascular diseases,  Cerebrovascular accident, Metabolic syndrome and Hypertension. Hyperlipidemia is described as elevated serum levels of Cholesterol or Triglycerides or both.

 
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