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CTRI Number  CTRI/2024/09/074046 [Registered on: 19/09/2024] Trial Registered Prospectively
Last Modified On: 02/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Efficacy of Talapatra Kshara(Alkali of palm leaves) in Cholesterol levels 
Scientific Title of Study   Efficacy of Talapatra Kshara in Medoroga W.S.R to Dyslipidemia- A Randomized Controlled Clinical Trial 
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 Subhrajyoti Moharana 
Designation  PG Scholar 
Affiliation  KAHERs Shri B.M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi 
Address  Department Of Swasthavritta KAHERs Shri B.M Kankanawadi Ayurved Mahavidyalaya Shahapur Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  7381218856  
Fax    
Email  subhrajyotimoharana2000@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ashok Patil 
Designation  HOD and Professor 
Affiliation  KAHERs Shri B.M Kankanawadi Ayurved Mahavidyalaya Shahapur Belagavi 
Address  Department Of Swasthavritta KAHERs Shri B.M Kankanawadi Ayurved Mahavidyalaya Shahapur Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  9972583954  
Fax    
Email  ashokpatil.kaher@kleayurworld.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Ashok Patil 
Designation  HOD and Professor 
Affiliation  KAHERs Shri B.M Kankanawadi Ayurved Mahavidyalaya Shahapur Belagavi 
Address  Department Of Swasthavritta KAHERs Shri B.M Kankanawadi Ayurved Mahavidyalaya Shahapur Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  9972583954  
Fax    
Email  ashokpatil.kaher@kleayurworld.edu.in  
 
Source of Monetary or Material Support  
KLE Ayurveda Hospital & Research Centre Shahapur Belgavi Karnataka 590003 
 
Primary Sponsor  
Name  Dr Subhrajyoti Moharana 
Address  Department Of Swasthavritta KAHERs Shri B.M Kankanawadi Ayurved Mahavidyalaya Shahapur Belagavi 590003 
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 Subhrajyoti Moharana  KLE Ayurveda Hospital Shahapur Belagavi Karnataka  Department of swasthavritta Room no 17 (Sumeda)
Belgaum
KARNATAKA 
7381218856

subhrajyotimoharana2000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Research on Human Subjects  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E785||Hyperlipidemia, unspecified. Ayurveda Condition: MEDOROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Atorvastatin10mg OD for 30 days (1tab HS)
2Intervention ArmDrugClassical(1) Medicine Name: Talapatra Kshara, Reference: Bruhat Nighantu Ratnakara, Medoroga Nidana Chikitsa, Route: Oral, Dosage Form: Kshara , Dose: 1(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Manda with Shuddha Hingu), Additional Information: Manda (50ml) with Shuddha hingu (500mg)
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Subjects between the age group of 20 - 50 years irrespective of gender, religion, occupation, and socioeconomic status.

Abnormal serum lipid levels like serum cholesterol (201 mg/dl or more), serum TGLs (161 mg/dl or more), serum HDL (below 40 mg/dl), serum LDL (131 mg/dl or more), and serum VLDL (41 mg/dl or more)

Having clinical features of Medoroga.
 
 
ExclusionCriteria 
Details  Subjects below 20 years and above 50 years of age.

Patient with a history or evidence of systemic disorders like Cardiac, renal & neurological diseases. Diseases including Diabetes mellitus, Liver cirrhosis, Hypertension & other malignancy.

Pregnant and lactating women
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Lipid profile including
a) Serum Cholesterol
b) Serum Triglycerides
c) Serum HDL
d) Serum LDL
e) Serum VLDL 
Baseline, Day 15, day 31 
 
Secondary Outcome  
Outcome  TimePoints 
Subjective Parameters
a) Difficulty in doing routine work (Sarva karmasu Ashaktata)
b) Exertional dyspnoea (Kshudra shvasa)
c) Excessive sweating (Svedadhikya)
d) Generalised weakness (Daurbalyata)
 
Baseline, Day 15,day 31 
 
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)   17/12/2024 
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 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 rapid rise of non-communicable diseases represents one of the major challenges to global development in the new century. Each year more than 15 million people die from NCD; 85% of these ‘premature’ deaths occur in low- and middle-income countries. According to WHO’s projections, the total annual number of deaths from NCDs will increase to 55 million by 2030. Global economic and social development is threatened by this emerging challenge.

Dyslipidemia is an extremely important condition, principally because of its contribution to atherogenesis and it is an independent and modifiable risk factor for CAD. The incidence of dyslipidemia is increasing in many developed and developing countries mainly due to the westernization of diet and sedentary lifestyles. 

According to the ICMR–INDIAB Study, over three-fourths (79%) of the general adult population covered in the survey have abnormalities in at least one of the lipid parameters with no urban-rural difference. Even the youngest age group has high rates of dyslipidemia.  The prevalence of dyslipidemia [as defined by National Cholesterol Education Program (NCEP) guidelines] in Indians is very high, with 79% of subjects having at least dyslipidemia, 72.3% subjects had high cholesterol in the high-density lipoprotein (HDL-C) level, 29.5% of subjects had hypertriglyceridemia and 11.8% of subjects had elevated low-density lipoprotein cholesterol (LDL-C). Therefore, optimal management of dyslipidemia along with management of other risk factors is essential to prevent the AS, and CVD pandemic 

Statins are the first choice in the treatment of dyslipidemia. The data from the US National Health and Nutrition Examination Survey conducted from 1999 to 2000 reported that 25% of adults either had total cholesterol >239.4 mg/dl or were taking a lipid-lowering medication. Lifestyle modifications should always be a part of the management of dyslipidemia. However, the need for long-term, lifelong therapy is associated with several adverse effects such as myopathy, increased risk of renal failure, hypothyroidism, and memory loss in 15%-20% of the patients on treatment with statins. 

 

“Ksharas” are known for their lekhana, karshana, kaphahara, and medohara actions . According to Sushruta, it is Naati Tikshna, Naati mrudu, Shighra Prabhavakai. Since Talapatra is widely accessible and used for conditions like Medoroga, Mutrakrichra, Mutraghata, swasa the study is intended to prepare talapatra kshara. TalaPatra Kshara has received little attention from researchers in recent years, but it’s theoretical underpinnings and historical applications make it a promising candidate for Medoroga.

Based on the above facts, to get a way through the burning issues of Medoroga, the present study has been planned.

 
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