| CTRI Number |
CTRI/2023/01/048772 [Registered on: 05/01/2023] Trial Registered Prospectively |
| Last Modified On: |
25/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of Aarogyavardhini Vati and Navak Guggulu with Triphala Kwath in Obesity. |
|
Scientific Title of Study
|
To Study the Effect of Aarogyavardhini Vati and Triphala Kwath Against Navak Guggulu and Triphala Kwath in Sthaulya with special reference to Obesity: Randomized control Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohini Hanumant Jamale |
| Designation |
PG 1st Year |
| Affiliation |
Government Ayurved College,Nagpur |
| Address |
Department of
Kayachikitsa, OPD No
1, Government Ayurved
College and Hospital,
Sakkardara Square,
Nagpur
Nagpur
MAHARASHTRA
440009
India |
| Phone |
8856059854 |
| Fax |
|
| Email |
mohinijamale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jayant Gulhane |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurved College,Nagpur |
| Address |
Department of
Kayachikitsa, OPD No
1, Government Ayurved
College and Hospital,
Sakkardara Square,
Nagpur
Nagpur
MAHARASHTRA
440009
India |
| Phone |
9822922399 |
| Fax |
|
| Email |
jayant.gulhane.62.6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohini Hanumant Jamale |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurved College,Nagpur |
| Address |
Department of
Kayachikitsa, OPD No
1, Government Ayurved
College and Hospital,
Sakkardara Square,
Nagpur
Nagpur
MAHARASHTRA
440009
India |
| Phone |
8856059854 |
| Fax |
|
| Email |
mohinijamale@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurved College and Hospital,Nagpur |
|
|
Primary Sponsor
|
| Name |
Government Ayurved College and Hospital |
| Address |
Goverment Ayurved College and Hospital, Sakkardara square,
Nagpur |
| Type of Sponsor |
Government medical college |
|
|
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 Mohini Jamale |
Government Ayurved College and Hospital |
Department of
Kayachikitsa, OPD No
1, Government Ayurved
College and Hospital,
Sakkardara Square,
Nagpur
Nagpur
MAHARASHTRA |
8856059854
mohinijamale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Ayurved College Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E669||Obesity, 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: Pandey R., Yogratnakar, chaukhambha vishwabharati prakashan, 2019, Adhyay 40/21, page no.593., Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Ushnodaka), Additional Information: -(2) Medicine Name: Triphala Kwath, Reference: Mishra S.N., Rasaratnasamucchaya, Chaukhambha Orientalia, Varanasi, 2011, Uttarkhand, Visarparoga Aadhyaya 20/91-97, page no. 576-577., Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Aarogyavardhini Vati, Reference: Mishra S.N., Rasaratnasamucchaya, Chaukhambha Orientalia, Varanasi, 2011, Uttarkhand, Visarparoga Aadhyaya 20/91-97, page no. 576-577., Route: Oral, Dosage Form: Kalka/ Paste , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: ushnodaka), Additional Information: -(2) Medicine Name: Triphala Kwath, Reference: Mishra S.N., Rasaratnasamucchaya, Chaukhambha Orientalia, Varanasi, 2011, Uttarkhand, Visarparoga Aadhyaya 20/91-97, page no. 576-577., Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having clinical features of Sthaulya (>50%) according to classics.
2.Patients of Sthaulya having BMI more than 25Kg/m2 and less than 40Kg/m2.
3.Patients of either sex of age between 18- 60 years are included.
4.Those patients of Sthaulya who are willing to participate in study and ready to give written consent will be included.
5.Patient who had not participated in any research work since last six months will be included.
|
|
| ExclusionCriteria |
| Details |
1.Patients of Sthaulya having BMI less than 25Kg/m2 and more than 40Kg/m2 will be excluded.
2.Patients having age below 18yrs and above 60yrs will be excluded.
3.Patients of Obesity due to hypothyroidism and Obesity with having clinical history of any other systemic disorders like Ischemic heart disease Patients with complicated and chronic disorder like Nephrotic syndrome, Jaundice, Hepatitis, chronic infections and other serious diseases will be excluded.
4.Patients of Sthaulya with uncontrolled hypertension (systolic BP>140mmHg and diastolic BP >100mmHg) and uncontrolled diabetes (Fasting >130mg/dl and Post meal>200mg/dl) mellitus will be excluded.
5.Patients of drug induced Obesity for example Hormonal replacement therapy, consumption of anabolic steroids etc. and any drugs that may influence on the outcome of the study will be excluded.
6.Pregnant females & lactating mothers will be excluded.
7.Patients who are currently participating in other clinical trials (since last six months) will be excluded.
8.Patient with evidence of malignancy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Aarogyavardhini Vati and Triphala Kwath in Sthaulya w.s.r. to Obesity on symptoms of Sthaulya during period of 30 days. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the efficacy of Aarogyavardhini Vati and Triphala Kwath with Navak Guggulu and Triphala Kwath in Sthaulya wsrt Obesity.
2.To evaluate the efficacy of Aarogyavardhini Vati and Triphala Kwath in Sthaulya w.s.r. to Obesity on BMI and circumference of waist and hip.
3.To study the literature of Sthaulya as per Ayurvedic perspective.
4.To study the literature of Obesity as per modern texts.
|
30 Days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/01/2023 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [mohinijamale@gmail.com].
- For how long will this data be available start date provided 29-12-2022 and end date provided 03-12-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
After Institutional Ethics Clearance of Government Ayurved College, Nagpur Screening of Population will be done from Patients in OPD, IPD, Casualty and Periphery of our institute. In the Clinical study 80 Patients of Sthaulya will include. Assessment of Symptoms will be done according to Scoring pattern by Gradation of Symptoms: Pattonder, R. K. et al (2011). During the informed consent process the subjects were given enough time to read patient information sheet and consent form. Subjects will also given freedom to ask the questions and all the questions would be answered.If he/she agrees for participation in the study and if found fit to include during screening then he will be recruited in the study. If all inclusion criteria is YES and all exclusion NO then subjects will be included on the basis of criteria given. Subjects will then undergo general and systemic examinations.
Parallel study design of Groups and Drugs Given in Respective Groups
| Group A | Group B | | Assessment on zero-day
| Assessment on zero-day | | Aarogyavardhini Vati 500mg 1BD with Lukewarm water Triphala Kwath 50 ml BD for 15 days With Sthaulyahar Aahar Vihar | Navak Guggulu 500mg 2TDS with Lukewarm water Triphala Kwath 50 ml BD for 15 days With With Sthaulyahar Aahar Vihar | | Administrated of drug by oral route
| Administrated of drug by oral route | | Assessment on 16th day and after completion of treatment. | Assessment on 16th day and after completion of treatment. | | Collection of data and analysis | Collection of data and analysis |
Medium of Dissertation: The study will be written in English and Sanskrit words will be used wherever necessary. Type of Study: A Randomised control trial. Duration of Treatment: Total 45 days. Ethical Clearance: Clearance from Institutional Ethics Committee of our institute. Study Centre: OPD,IPD of Kayachikitsa and Casualty of our institute and periphery of Nagpur Duration of study: study will be carried out for 18 months after approval of synopsis.
Treatment Regimen: Group A
| Treatment given | Duration | Dose | Anupana | Bheshaja Sevankala | | Aarogyavardhini Vati | 30 days | 500mg 1BD | Ushnodak | Before Morning Meal after Afternoon Meal | | Triphala Kwath | 30days | 50 ml | ---- | Before Morning and Afternoon Meal |
Group B
| Treatment given | Duration | Dose | Anupana | Bheshaja Sevankala | | Navak Guggulu | 30 days | 500mg 2TDS | Ushnodak | Before and after morning And after Afternoon Mea | | Triphala Kwath | 30days | 50 ml | ---- | Before Morning and Afte Meal | |