| 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
|
|
|
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
|
|
|
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) | | - | Atorvastatin | 10mg OD for 30 days (1tab HS) | | 2 | Intervention Arm | Drug | Classical | | (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. |