| CTRI Number |
CTRI/2025/02/079864 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [therapeutic clinical] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Effect of Guduchyadi Yoga and Navak Guggulu in the management of Medoroga (Dyslipidaemia) |
|
Scientific Title of Study
|
Comparative clinical study to evaluate the efficacy of Guduchyadi Yoga with Navak Guggulu in Medoroga w.s.r. Dyslipidaemia- a Randomized controlled 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 Komal Shahu |
| Designation |
MD scholar kayachikitsa |
| Affiliation |
Chaudhary brahm prakash ayurved charak sansthan |
| Address |
PG department of kayachikitsa,
Chaudhary brahm prakash ayurved charak sansthan, najafgarh, khera dabar, new delhi 110073
South West
DELHI
110073
India |
| Phone |
9754672367 |
| Fax |
|
| Email |
shahukomal24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr N R Singh |
| Designation |
Head of department, Kayachikitsa |
| Affiliation |
Chaudhary brahm prakash ayurved charak sansthan |
| Address |
PG department of kayachikitsa, Chaudhary brahm prakash ayurved charak sansthan, najafgarh, khera dabar, new delhi 110073
South West
DELHI
110073
India |
| Phone |
9560659728 |
| Fax |
|
| Email |
naimishraj@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr N R Singh |
| Designation |
Head of department, Kayachikitsa |
| Affiliation |
Chaudhary brahm prakash ayurved charak sansthan |
| Address |
PG department of kayachikitsa, Chaudhary brahm prakash ayurved charak sansthan, najafgarh, khera dabar, new delhi 110073
South West
DELHI
110073
India |
| Phone |
9560659728 |
| Fax |
|
| Email |
naimishraj@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Chaudhary brahm prakash ayurved charak sansthan, najafgarh, khera dabar, new delhi 110073 |
|
|
Primary Sponsor
|
| Name |
Chaudhary brahm prakash ayurved charak sansthan |
| Address |
Chaudhary brahm prakash ayurved charak sansthan, najafgarh, khera dabar, new delhi 110073 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Komal Shahu |
Chaudhary brahm prakash ayurved charak sansthan |
room no. 108, PG department of kayachikitsa, Chaudhary brahm prakash ayurved charak sansthan, khera dabar, Najafgarh, new delhi, India 110073
South West
DELHI |
9754672367
shahukomal24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical commitee chaudhary brahm prakash ayurved charak sansthan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E789||Disorder of lipoprotein metabolism, unspecified. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Navak guggulu, Reference: bhaishajya ratnavali medorogadhikara shlok no. 42, Route: Oral, Dosage Form: Guggulu , Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: warm water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Guduchyadi yoga, Reference: Yogratnakar chapter no. 40 shlok no. 6, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a. Already Diagnosed cases of Dyslipidaemia based on investigation within 1 month of period.
b. Subjects with any one or more Lakshana of Medoroga.
c. Subjects with any one or more of the following parameter - Total Cholesterol above 200mg/dl and upto
400mg/dl, Triglycerides above 150 mg/dl and upto 300 mg/dl or HDL below 40mg/dl and upto 20 mg/dl
or LDL above 100mg/dl and upto 200 mg/dl or VLDL above 30mg/dl to 60 mg/dl.
d. Subjects between the age group of 21-60 years of either sex.
e. Subjects who are ready to give consent with firm home address and contact no. which is readily
accessible during coarse of trial. |
|
| ExclusionCriteria |
| Details |
a. Subjects with total cholesterol above 400mg/dl or Triglycerides above 300 mg/dl or LDL cholesterol
above 200mg/dl or HDL cholesterol below 20mg/dl, VLDL above 60 mg/dl.
b. Subjects having Insulin dependent Diabetes Mallitus and uncontrolled DMT2 even after using OHA.
c. Subjects with uncontrolled Hypertension -BP greater than 150/90 mm of Hg.
d. Subjects having major systemic illness except patients of obesity, controlled DMT2, controlled patients
of Hypertension.
e. Subject below 21 years and above 60 years of age.
f.
History of adverse reaction to any trial drug or their ingredients.
g. Pregnant females and lactating mothers.
h. Subjects who are already registered in any other research project.
i.
Subjects who are not willing for the trial. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in the hematological parameters of dyslipidaemia
Total cholesterol: Levels below 200 mg/dL
Triglycerides: levels below 150 mg/dL
LDL cholesterol: Levels below 100 mg/dL
HDL cholesterol: Levels above 40 mg/dL in men and above 50 mg/dL in women
VLDL cholesterol: levels below 30 mg/dL
|
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in Clinical features of Medoroga
a) Kshudra Shwasa (Breathlessness)
b) Trishna (Polydipsia)
c) Nidraadhikya (Excessive sleep)
d) Kshudha Atimatra (Excessive hunger)
e) Swedadhikya (Excessive sweating)
f) Daurgandhya (Bad odour of body)
g) Alpa Prana (Fatigue) |
90 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
10/02/2025 |
| 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 - NO
|
|
Brief Summary
|
The term Medoroga was first used by Acharya Madhava to define obesity and related lipid disorder.
In Ayurvedic classics, in reference to “Medoroga†two types of Meda(fat) are described viz. Baddha Meda
and Abaddha Meda.
Baddha Meda - the fat which is not mobile and is stored in the form of fat at various places (fat depot/
omentum/ muscles in the body). Abaddha Meda - the fat which is mobile and circulates in the body along with blood in the form of lipids
(cholesterol, triglycerides, LDL, HDL and VLDL).
According to Madhava Nidana, Nidana of Medoroga are lack of exercise, sleeping in day time, increase
intake of Kaphavardhaka Ahaar Vihaar. The person with Medo
Roga will have Kshudra Shwas (breathlessness), Trishna (excessive thirst), Moha, Swapna (excessive
sleep), Krathana (Sudden obstruction of breath), Sadana (looseness of the body) Kshuta (Excessive
hunger), Sweda (excessive sweating), Daurgandhya (foul body smell), Alpa prana (Fatigue), Alpa
Maithuna (loss of libido). Dyslipidaemia is defined as a disorder of lipoprotein metabolism, it refers to lipid abnormalities consisting
of either one or any combination of elevated total cholesterol (TC), elevated triglycerides (TG), elevated
low- density lipoprotein (LDL-c) or low high-density lipoprotein (HDL-c). Dyslipidaemia is one of the
major health problems in both developed as well developing country and arising as a result of combination
of some genetic factors, environmental factors like sedentary lifestyle, rapid urbanization, underactive
thyroid gland, obesity, nutritional advancement accompanying economic development, excess alcohol
intake and other associated medical conditions. In general, its prevalence increases with age. Indian Council of Medical Research (ICMR) reported a
prevalence of dyslipidaemia of 37.5% among adults aged between 15 to 64 years, with an even higher
prevalence of dyslipidaemia (62%) among young male industrial workers. The present study aims to evaluate the Comparative effect of Guduchyadi Yoga with Navak Guggulu in the management of Medoroga ~ Dyslipidaemia. the total number of patient is 60, 30 in each group In group A, Navak Guggulu will be administered in a dose of 1 gm twice daily with warm water 1 hour after meals. In group B, Guduchyadi Yoga will be administered in a dose of 5 gm twice daily with madhu (honey) 1 hour after meals. the design of the study is single centered, open label, Randomized comparative and interventional study. |