| CTRI Number |
CTRI/2025/02/081213 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Yogic management of Medoroga |
|
Scientific Title of Study
|
Efficacy of Common Yoga Protocol as add on intervention along with Navaka Guggulu in the management of Medoroga w.s.r. to Dyslipidemia an open labelled randomized comparative 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 |
Sakshi Jatte |
| Designation |
M.D. Scholar |
| Affiliation |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
Department of Swasthavritta, Dhanvantari Mandir, ITRA, Jamnagar, Gujarat 361008
Opposite to Reliance Smart Mall,Gurudwara Road,Jamnagar, Gujarat 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
7020438517 |
| Fax |
|
| Email |
smjatte@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VdArpan A Bhatt |
| Designation |
Professor and Head |
| Affiliation |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
Department of Swasthavritta, Dhanvantari Mandir, ITRA, Jamnagar, Gujarat 361008
Opposite to Reliance Smart Mall, Gurudwara Road,Jamnagar, Gujarat 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9998968727 |
| Fax |
|
| Email |
vdarpansoniac@itra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
VdArpan A Bhatt |
| Designation |
Professor and Head |
| Affiliation |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
Department of Swasthavritta, Dhanvantari Mandir, ITRA, Jamnagar, Gujarat 361008
Opposite to Reliance Smart Mall, Gurudwara Road, Jamnagar, Gujarat 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9998968727 |
| Fax |
|
| Email |
vdarpansoniac@itra.edu.in |
|
|
Source of Monetary or Material Support
|
| Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat 361008 |
|
|
Primary Sponsor
|
| Name |
Institute of Teaching and Research in Ayurveda |
| Address |
Opposite to Reliance Smart, ITRA, Jamnagar, Gujarat 361008 |
| 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 |
| Sakshi Jatte |
Institute of Teaching and Research in Ayurveda, Jamnagar |
OPD No.14, Department of Swasthavritta, Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat
Jamnagar
GUJARAT |
7020438517
smjatte@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Institute of Teaching and Reasearch in Ayurveda Jamnagar, Gujarat, 361008 |
Approved |
|
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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 | Drug | Classical | | (1) Medicine Name: Navaka Guggulu , Reference: Shri Ambika Datta Shastri, Bhaishajya Ratnavali, Chapter 39 Ver. 43 11th Edition, Chaukhamba Sanskrit Sansthana, Varanasi , Route: Oral, Dosage Form: Guggulu , Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Lukewarm water ), Additional Information: - | | 2 | Intervention Arm | Procedure | - | Common Yoga Protocol | (Procedure Reference: Ministry of Ayush, Goverment of India , Procedure details: Pranadharna, susbtle exercise,Asana, Pranayama, Dharana
60 minutes per day )
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Willing patients between 18 to 60 years of age and BMI Between 18.5kg/m2 to 29.9 kg/m2 having any 02 symptoms viz. Kshudrashwas, Trisha, Swapna, Krathan, Sadan, Kshut, Sweda, Daurgandhya, Alpa Prana, Alpa Maithuna Anyone or more deranged parameters in the lipid profile Sr. cholesterol (more than 200mg/dl and less than 300mg/dl) Sr. Triglyceride (more than 150mg/dl and less than 350mg/dl) Sr. LDL (more than 130mg/dl) Sr. HDL (less than 40 mg/dl) Sr.VLDL (more than 40mg/dl) |
|
| ExclusionCriteria |
| Details |
1 patients below 18 years and above 60 years of age and who are not willing to participate, not physically fit to perform the common yoga protocol
2 Drug induced dyslipidemia
3 Disease induced secondary dyslipidemia
4 Dyslipidemia chronocity for more than 5 years
7 Females with Metrorrhagia
8 Pregnant or lactating females
9 Patient with other systemic disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Relief in symptom of Medoroga
2 Reduction in parameters of lipid profile |
3 times in 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Improvement in disturbed Manasbhavas of the patients of Medoroga
2 Reduction in Apo B Lipoprotein
3 Reduction in Sr. leptin level
|
3 times in 12 weeks |
|
|
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)
|
01/06/2025 |
| 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="0"
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 fast-growing technology, busy schedules, sedentary lifestyle and changes in dietary habits has made an individual prone to various Life Style Disorders. Dyslipidemia being one of them. Dyslipidemia involves abnormality in levels of any or all lipoproteins in the blood. Dyslipidemia is one of the risk factors for cardiovascular diseases. Worldwide, cardiovascular disease is now one of the most common causes of death. Dyslipidemia can be corelated to Medoroga as described in Ayurveda. High fatty diet (Snighdha, Guru, Pichhila) and Sedentary Lifestyle (Avyayama, Diwaswapa) may contribute to Medoroga. Apart from this nidana, mansika hetu also plays crucial role in manifestation of the disease. Navaka Guggulu has hypolipidemic activity as its maximum ingredients have Rasa – Katu, Virya – Laghu, Ruksha and Ushna, Vipaka – Katu, Vata – Kapha Shamaka. On the otherhand, Yoga is a practice of set of procedures which relieves mind-body stress that increases mental and physical health, which has a role in the improvement of metabolism. Common Yoga Protocol (C.Y.P.) is a standardized protocol for Yoga released by Ministry of AYUSH, Government Of India for International Day of Yoga since 2015, which incorporates practices like Pranadharna, subtle exercises, Asanas, Pranayama and Dhyana. Rationale For Selection of Topic: Dyslipidemia is one such disorder which is identified as a potential risk factor for multiple diseases like cardiovascular diseases, NAFLD, metabolic syndrome and even hypertension. Raised total cholesterol is a major cause of disease burden in the both developed and developing world as a risk factor for ischemic heart disease and stroke. In Gujrat, prevalence of Dyslipidemia according to the ICMR- INDIAB Study 2023 high total cholesterol (>200 mg/dl) is 18.1%, high LDL cholesterol (>130mg/dl) is 16% and high triglycerides (>150mg/dl) is 26.9%. Aim and Objectives: To evaluate the add on effect of Common Yoga Protocol (C.Y.P.) along with Navaka Guggulu in the management of Medoroga. Materials and Methods:30 individuals will be enrolled in two groups. Individuals in Group A will be given Navaka Guggulu for 90 days (2 gm / day divided into 2 doses orally 30 minutes after meals) while volunteers in Group B will be made to practice 60 minutes of Common Yoga Protocol (C.Y.P.) along with Navaka Guggulu (2 gm / day divided into 2 doses orally 30 minutes after meals) for 90 days. Results and Discussion: Data generated during the above study will be present in a Systemic manner as shall be analyzed statically. Where the important points of the review of literature, Conceptual study, Analytical study will be discussed. Follow up: After completion of procedure, 2 follow ups after completion of the treatment at the interval of 15 days.
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