| CTRI Number |
CTRI/2025/03/081654 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Prevention of obesity with medicine and selected daily regime procedures |
|
Scientific Title of Study
|
Efficacy of Ushahpana and Udvartana along with Tryushanadi Guggulu in the prevention of Sthaulya w.s.r to overweight-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 |
Akshay Prajapat |
| Designation |
M.D. Scholar |
| Affiliation |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
Department of Swasthavritta Dhanvantri Mandir ITRA Jamnagar
Institute of Teaching and Research in Ayurveda Jamnagar Gujarat
pin code 361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9049431579 |
| Fax |
|
| Email |
prajapatakshay679@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Arpan A Bhatt |
| Designation |
Professor and Head |
| Affiliation |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
Department of Swasthavritta Dhanvantri Mandir ITRA Jamnagar
Institute of Teaching and Research in Ayurveda Jamnagar Gujarat
pin code 361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9998968727 |
| Fax |
|
| Email |
vdarpansoniac@itra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Vd Arpan A Bhatt |
| Designation |
Professor and Head |
| Affiliation |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
Department of Swasthavritta Dhanvantri Mandir ITRA Jamnagar
Institute of Teaching and Research in Ayurveda Jamnagar Gujarat
pin code 361008
India
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 India |
|
|
Primary Sponsor
|
| Name |
Institute of Teaching and Research in Ayurveda |
| Address |
ITRA Jamnagar opposite to Reliance Smart |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Akshay Prajapat |
Institute of Teaching and Research in Ayurveda, Jamnagar |
OPD number 14
Department of
Swasthavritta Institute
of Teaching and
Research in Ayurveda
Jamnagar
Jamnagar
GUJARAT
Jamnagar
GUJARAT |
9049431579
prajapatakshay679@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Institute of Teaching and Research in Ayurveda, Jamnagar |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: ATISTHAULYAM (KEVALA-KAPHA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Tryushanadi Guggulu, Reference: Bhavprakasa of Bhavamisra, By Dr. Bulusu Sitaram, Prof. K.C Chunekar, Chaukhambha Orientalia, Varanasi, reprint edition 2020, Vol.1, Chapter 5, Shloka-304 Pg.95., Route: Oral, Dosage Form: Guggulu , Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: -given in vyana-udana kala | | 2 | Comparator Arm | Procedure | - | ushahpana | (Procedure Reference: Bhavprakasa of Bhavamisra, By Dr. Bulusu Sitaram, Prof. K.C Chunekar, Chaukhambha Orientalia, Varanasi, reprint edition 2020, Vol.1, Chapter 5, Shloka-303-304 Pg.95., Procedure details: At Ushah Kala (at the time of sunrise) 8 prasriti or 3 glasses or 750-768ml of potable water kept in copper vessel for night will be adviced to the patient for consumption)
| | 3 | Comparator Arm | Procedure | - | udvartanam, उद्वर्तनम् | (Procedure Reference: Susruta Samhita with English translation of text and Dalhan`s commentary, Vol.2, by P.V Sharma, reprint 2013 Chaukhambha Vishvabharati, Varanasi, Chikitsasthan, Chap.24, Shloka 51, pg. 497. , Procedure details: Panchakarma illustrated by Dr. G. Shrinivasa Acharya, Chaukhamba Sanskrit Pratishthan Delhi, reprint edition 2013, Upakrama, Udvartana pg. no. 162-166.)
(1) Medicine Name: Yava churna, Reference: Sushruta Samhita of Maharshi Susruta Ayurveda- Tattva-Sandipika Hindi commentary, by Kaviraja Ambikadutta Shastri, Chaukhambha Sanskrit Sansthan, Varanasi, Reprint 2020, Part 1, Chikitsasthana, chapter-29, Verse-12, Pg. No. 151, Route: Topical, Dosage Form: Churna/ Powder, Dose: 100(g), Frequency: od, Duration: 45 Days |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients who are willing to participate, presenting with at least 5 symptoms as per symptoms given in diagnostic criteria 1 viz. Kshudrashwaas (Dyspnoea on Exersion), Atipipasa (excess thirst), Swedadhikya (Excess sweating at normal temperature/in normal condition), Daurgandhya (Body odour), Atikshudha (excess hunger), Nidradhikya (Excess sleep), Bharavriddhi (increase in weight), ChalaSphikaUdaraStana (Visible Movement in Hip-Abdomen-Breast), Angagaurava (heaviness in body), Ayathopachaya (Improper distribution of fat)
2)Body mass index (BMI) 25 to 29.99 Kg/m2 Over weight according to WHO Criteria
3)Waisthip ratio Men more than 0.95 and Women more than 0.85
4)Deranged values of lipid profile parameters |
|
| ExclusionCriteria |
| Details |
1 Age less than 18 and more than 60 years and patients not willing to participate
2 Patients with Systemic Disorders like Diabetes mellitus both types, Hypertension, Liver cirrhosis, Fatty liver disease, Coronary heart disease, Renal diseases, Rheumatological disorders, Hypothyroidism, cancer, Bleeding disorders
3 Pregnant and lactating women
4 Patients suffering from infectious skin disorders and known c/o skin allergy
5 Patients on hormonal therapy and drugs |
|
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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 |
Relief in the symptoms of Sthaulya
Reduction or maintenance in body weight, BMI, Waist-Hip ratio, Skin-fold thickness, Anthropometry.
Reduction in values of parameters in deranged lipid profile
Decrease or normalization in serum Leptin hormone level
|
1 week,6 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in LFT values |
BT and AT within 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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
|
It is an open labelled randomized comparative clinical trial to study the efficacy of Ushahpana and Udvartana along with Tryushanadi Guggulu in the prevention of Sthaulya w.s.r to overweight. Ayurveda is the science of healthy living, which believes in preventive and promotive health. Acharya Charaka describes the state of wellness which says that one endowed with practice of Hita Ahara and Vihara Sevana, conscious deeds, charity etc is healthy, which all lack in the condition of disease. Obesity as a disease, often lacks the characteristics of wellness, such as vitality and resilience, and is instead associated with negative impacts on physical and mental health. As per Acharya Charaka, scraggy is better in comparison of obese (Sthula), because in spite of both these possessing equal means/assets (for treatment), the obese person suffers more due to difficulty in treatment. Ushahpana as a procedure of Dinacharya is now out dated or vanished from our daily practice or if exists than followed wrongly, this is also one of the matters of interference, also drinking cold water has also shown REE (Resting Energy Expenditure) elevation in adults, suggesting an idea to explore the concept of Ushahpana with regard to weight loss or maintenance. Acharya Sushruta while explaining Udvartana, says that it pacifies Vata and dissolves Kapha and Meda Dhatu all this three are contents of pathogenesis of Sthaulya (obesity), which indicates its beneficial use in prevention of obesity, being Sthula Vilekhanashcha, Yava is chosen for Udvartana. Tryushanadi Guggulu can quickly cure the diseases arising from Kapha, Vata and Medas, though severe hence, it’s used in overweight. Obesity is one of the most serious global public health challenges of the 21st century affecting every country therefore, World Health Organization has declared it as a global epidemic. According to National Family Health Survey, obesity prevalence rate in Gujarat state is 19.7% in males and 23.8% in females. The rate of obesity has increased to 3.9% in males and 3.1% in females respectively in 2022, the data is an alarming sign to find a remedy which is cost effective as well as feasible to prevent this life-threatening problem. Aim and Objectives:To assess the efficacy of Ushahpana and Udvartana along with Tryushanadi Guggulu, in the prevention of obesity w.s.r to overweight with regard to Leptin hormone levels. Materials and Methods: 45 patients with BMI ranging between 25-30 kg/m2, will be enrolled in three groups. Volunteers in Group A will be given Tryushanadi Guggulu along with Ushahpana for 45 days, while volunteers in Group B will be given Tryushanadi Guggulu along with Udvaratana with Yava choorna for 45 days and volunteers in Group C will receive only Tryushanadi Guggulu for oral consumption. Results and Discussion: Data generated during the above study will be present in a Systemic manner as shall be analyzed statistically. Where the important points of the review of literature, conceptual study, Analytical study will be discussed. Follow up: After completion of procedure, follow up will be done for 1 month at the interval of 15 days. ADR if any observed will be reported to the Pharmacovigilance cell of ITRA Jamnagar. |