CTRI/2025/07/091171 [Registered on: 18/07/2025] Trial Registered Prospectively
Last Modified On:
17/07/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug Ayurveda Diagnostic
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A Study on the effect of Dry Herbal Powder massage followed by Ayurvedic enema treatment using Varunadi and Ardhamatrika in people with High Cholestrol & Fat levels
Scientific Title of Study
Evaluating the Efficacy of Rookshana Purvaka Basti Karma with Varunadi Niruha and Ardhamatrika on Dyslipidemia - A randomized comparative clinical trial focused on Inflammatory and Lipid biomarkers
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 Dibyajyoti Moharana
Designation
Ph.D Scholar, Department of Panchakarma
Affiliation
Parul Institute of Ayurveda, Parul University
Address
Department of Panchakarma, Parul Institute of Ayurveda, Parul University, P.O. Ishwarpura-Limda, Taluka - Waghodia, Postal code: 391760, District - Vadodara, Gujarat, India,
Vadodara GUJARAT 391760 India
Phone
8984594494
Fax
Email
dibyajyotimoharana@gmail.com
Details of Contact Person Scientific Query
Name
Dr Sangeeta H Toshikhane
Designation
Professor, Department of Panchakarma
Affiliation
Parul Institute of Ayurveda, Parul University
Address
Department of Panchakarma, Parul Institute of Ayurveda, Parul University, P.O. Ishwarpura-Limda, Taluka - Waghodia, Postal code: 391760, District - Vadodara, Gujarat, India,
Vadodara GUJARAT 391760 India
Phone
9964596479
Fax
Email
drsangeetaj@gmail.com
Details of Contact Person Public Query
Name
Dr Sangeeta H Toshikhane
Designation
Professor, Department of Panchakarma
Affiliation
Parul Institute of Ayurveda, Parul University
Address
Department of Panchakarma, Parul Institute of Ayurveda, Parul University, P.O. Ishwarpura-Limda, Taluka - Waghodia, Postal code: 391760, District - Vadodara, Gujarat, India,
Vadodara GUJARAT 391760 India
Phone
9964596479
Fax
Email
drsangeetaj@gmail.com
Source of Monetary or Material Support
Department of Panchakarma, Parul Institute of Ayurveda, Parul University, P.O. Ishwarpura-Limda, Taluka - Waghodia, Postal code: 391760, District - Vadodara, Gujarat, India.
Primary Sponsor
Name
Dr Dibyajyoti Moharana
Address
Department of Panchakarma, Parul Institute of Ayurveda, Parul University, P.O. Ishwarpura-Limda, Taluka - Waghodia, Postal code: 391760, District - Vadodara, Gujarat, 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 Dibyajyoti Moharana
Sri Sri College of Ayurvedic Science and Research Hospital, Sri Sri University
Department of Panchakarma, Room no C-04, Sri Sri College of Ayurvedic Science and Research Hospital, Sri Sri University, Sri Sri Vihar, Bidyadharpur, Ward no 03, Godi Sahi, Cuttack-754006, Odisha, India Cuttack ORISSA
08984594494
dibyajyotimoharana@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
The Parul University Institutional Ethics committee for Human Research
(Procedure Reference: Charaka Samhita, Siddhi Sthana, Chapter 7 : Basti Vidhi, Procedure details: As a part of Purva Karma, Sthanika Abhyanga with Moorchita Tila Taila over the lower back & abdomen for 15 minutes followed by Nadi Sweda for 15 minutes.
As a part of Pradhana Karma, 72 ml of Moorchita tila taila Anuvasana basti & 576 ml of Varunadi Niruha basti administered in form of Modified Kala Basti Schedule of total 16 days.
As a part of Paschat Karma, Rogi Parichara, Avoiding Ashta Maha Doshakara Bhavas & Intake of Laghu Supachi ahara.
) (1) Medicine Name: Moorchita tila taila, Reference: Sharangadhara Samhita, Madhya Khanda, Chapter 09: Sneha Kalpa, Route: Rectal, Dosage Form: Taila, Dose: 72(ml), Frequency: od, Duration: 5 Days(2) Medicine Name: Varunadi Niruha, Reference: Modified Niruha basti Formulation by using Varunadi Gana - Ashtanga Hridaya, Sutra Sthana 15/21-22, Route: Rectal, Dosage Form: Not Applicable, Dose: 576(ml), Frequency: od, Duration: 11 Days
(Procedure Reference: Charaka Samhita, Siddhi Sthana, Chapter 07, Basti Vidhi, Procedure details: As a part of Purva Karma, Sthanika Abhyanga with Moorchita Tila Taila over the lower back & abdomen for 15 minutes followed by Nadi Sweda for 15 minutes.
As a part of Pradhana Karma, 72 ml of Moorchita tila taila Anuvasana basti & 624 ml of Ardhamatrika basti administered in form of Modified Kala Basti Schedule of 16 days.
As a part of Paschat Karma, Rogi Parichara, Avoiding Ashta Maha Doshakara Bhavas & Intake of Laghu Supachi ahara.
) (1) Medicine Name: Moorchita tila taila, Reference: Sharangadhara Sahmita, Madhayama Khanda, Chapter 09: Sneha Kalpa, Route: Rectal, Dosage Form: Taila, Dose: 72(ml), Frequency: od, Duration: 5 Days(2) Medicine Name: Ardhamatrika Basti, Reference: Vangasena Samhita, Bastikarma Adhikara, Route: Rectal, Dosage Form: Not Applicable, Dose: 624(ml), Frequency: od, Duration: 11 Days
Inclusion Criteria
Age From
20.00 Year(s)
Age To
50.00 Year(s)
Gender
Both
Details
Patients willing for trail, is the first & foremost criteria.
Subjects between the age group of 20 - 50 years irrespective of gender, religion, occupation and socioeconomic status.
Abnormal serum lipid levels like Total cholesterol (200 mg/dl or more) , serum triglycerides (150 mg/dl or more), serum HDL (below 40 mg/dl) , serum LDL (130 mg/dl or more), and serum VLDL (30 mg/dl or more) . Patient having one or any of these.
Having the clinical features of Dyslipidemia.
Subjects fit for Basti Karma.
Patients of Dyslipidemia with Controlled Hypertension, Controlled Hypothyroidism and Controlled diabetes mellitus.
ExclusionCriteria
Details
Subjects below 20 years and above 50 years of age.
Subjects unfit for Basti Karma.
Patients with Angina, myocardial infraction, stroke, transient ischemic attack, heart and vascular surgery or major operations within 6 months prior to screening visit.
Patient with a history or evidence of systemic disorders like Cardiac, hepatic, renal & neurological diseases. Diseases including Uncontrolled Diabetes mellitus, Liver Cirrhosis, Uncontrolled Hypothyroidism, Uncontrolled 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
a)lipid profile that includes serum total cholesterol, serum triglycerides, serum HDL, serum LDL & serum VLDL.
b)Inflammatory Bio markers that includes CRP, Interleukin (IL)-6, Serum ferritin, ESR
c)Lipid bio markers that includes Apolipoprotein B
d)Other Objective parameters are body weight in Kg, BMI ( Body Mass index ), SGOT, SGPT
Baseline, Day 7, Day 23
Secondary Outcome
Outcome
TimePoints
a)Fatigue
b)Chest Discomfort
c)Shortness of breath
d)Palpitations
e)Changes in Skin / Xanthelesma.
Baseline, Day 7, Day 23
Target Sample Size
Total Sample Size="160" Sample Size from India="160" 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)
28/07/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
28/07/2025
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="1" 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
Dyslipidemia is an extremely important condition, principally because of
its contribution to atherogenesis and it is an independent and modifiable risk
factor for CAD. Incidence of dyslipidemia is increasing in many developed and
developing countries mainly due to westernization of diet and sedentary
lifestyle
According to
the ICMR–INDIAB Study, over three-fourth (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).
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.
According to Madhava nidana, Medoroga nidana adhyaya and Charaka Samhita
sutrasthana, Santarpaneeya adhyaya, the sign and symptoms of Medo vriddhi or
Medo dushti have striking similarities with the disease Dyslipidemia. It can be
classified as medo roga under Santarpanajanya vyadhi based on the etiological
components and symptom complexes. Chikitsa sutra of Santarpana vyadhi primarily
comprises of Apatarpana chikitsa. Basti appears to best among all the treatment
modalities under Samshodhana chikitsa. Since it is the fastest Apatarpana
Chikitsa that can eliminate excessively vitiated Kapha-medo dhatu by virtue of
its lekhana and Doshanirharana karma.
Even rukshana karma, one among apatarpana chikitsa, especially Udwartana
play a key or important role in the management of Dyslipidaemia by virtue of
its Kapha hara and Vilayana karma / liquification of dushita medo dhatu.
Considering all the above factors, here an attempt has been made to critically
evaluate the efficacy of Rookshana Purvaka Basti Karma with Varunadi Niruha and
Ardhamatrika on dyslipdemia, focusing on inflammatory and lipid bio marker.