| CTRI Number |
CTRI/2023/11/059848 [Registered on: 15/11/2023] Trial Registered Prospectively |
| Last Modified On: |
06/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect Of Haritaki and Dhanvayas in the Management Of Obesity |
|
Scientific Title of Study
|
A Comparative Study to Evaluate the Efficacy Of Haritaki and Dhanvyas in the Management Of Sthaulya (Obesity) w.s.r. to Antihyperlipidaemic Activity |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yashika Sharma |
| Designation |
MD Scholar |
| Affiliation |
Ayurveda and Unani tibbia college Karol Bagh New Delhi |
| Address |
PG Department of Dravyaguna
Ayurveda and Unani tibbia college Karol Bagh New Delhi
Central
DELHI
110005
India |
| Phone |
8219151269 |
| Fax |
|
| Email |
syashika215@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Sharma |
| Designation |
Associate Professor |
| Affiliation |
Ayurveda and Unani tibbia college Karol Bagh New Delhi |
| Address |
PG Department of Dravyaguna
Ayurveda and Unani tibbia college Karol Bagh New Delhi
Central
DELHI
110005
India |
| Phone |
9868092250 |
| Fax |
|
| Email |
rajsakshi.sharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Sharma |
| Designation |
Associate Professor |
| Affiliation |
Ayurveda and Unani tibbia college Karol Bagh New Delhi |
| Address |
PG Department of Dravyaguna
Ayurveda and Unani tibbia college Karol Bagh New Delhi
Central
DELHI
110005
India |
| Phone |
9868092250 |
| Fax |
|
| Email |
rajsakshi.sharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurvedic and unani tibbia college and hospital, Karol Bagh , New Delhi-05 |
|
|
Primary Sponsor
|
| Name |
Ayurvedic and Unani Tibbia College |
| Address |
Ayurvedic and Unani Tibbia College and Hospital Karol Bagh New Delhi 110005 |
| 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 Rajesh Sharma |
Ayurvedic and Unani Tibbia College and Hospital |
Opd no 18 PG Department of Dravyaguna
Ayurveda and Unani tibbia college Karol Bagh New Delhi
Central
DELHI |
9868092250
rajsakshi.sharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee AUTCH |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: haritaki churna, Reference: charak samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: dhanvyas, Reference: bhavprakash, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients between the age group of 18-60 years of either sex.
2. Willing and able to participate in the study for 90 days.
3. BMI >30.00kg/m2 and BMI < 40 kg/m2.
4. Patient not taking any oral conventional medicine.
5. Patients having associated symptoms according to Ayurvedic classification of
Sthaulya (Obesity) like Chalsphikudarstana, Swedadhikya, Atiskhudha,
KshudraSwasa, Angagaurava , Anga Chalatva ,Atipipasa, Avyavaya. |
|
| ExclusionCriteria |
| Details |
1. The patient having B.M.I. >40.
2. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome,
Myocardial Infarction, congestive heart failure, Stroke or severe Arrhythmia,
Unstable angina in the last six months.
3. Patients on prolonged (>6weeks) medication with corticosteroids, antidepressants,
anticholinergics, immunosuppressant, estrogen replacement therapy etc. or anyother drugs that may have an influence on the outcome of the study and patientson oral contraceptives.
4. Patients with poorly controlled hypertension (systolic >140 and diastolic >90 mmof Hg) despite of antihypertensive agents.
5. .Patients having history of diabetes i.e (HbA1c > 6.5%)
6. Hypothyroidism .
7. Pregnancy and Lactating mother.
8. Patient who has participated in any clinical trial in past 6 Months. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparative evalauation of Both the drug i.e. Haritaki churna and Dhanvyas churna would be assessed on -disappearance of clinical symptoms of sthaulya as per questionaire and improvement in Lipid Profile of subjects, BMI,Subjective/Objective parameters , Girth measurements asfrom baseline and after 90 days of therapy |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pharmacognostical and Phytochemical evalaution of the drug would be done from GMP certifiedlab.
Improvement in Health conditions as per SF-36 Health survey.
At the end of the study,Safety of drug can be noted with any adverse effect and the five -point Global Assessment scale for efficacy(very much improved,much impoved,Improved,Mildly improved,worse) will be used |
3 months |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
01/12/2023 |
| 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)
|
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 - 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 - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- 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 [syashika215@gmail.com].
- For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2030?
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
|
Obesity/Overweight is a global epidemic resulting from sedentary lifestyles, improvedsocioeconomic conditions and availability of processed ,high calorie foods and soft drinks inindustrialized societies. Approximately 35% of US adult population is overweight, and anadditional 30 % of adults are obese; the prevalence of obesity in children and adolescents isalso increasing indeed reaching epidemic proportions . As obesity is correlated with increasedmorbidity and mortality , it is important to define and recognize it, to understand its causesand to be able to initiate appropriate measures to prevent or manage it. Behavioral and dietarychanges are the initial therapeutics strategies; weight loss drugs are used but due to their
side effects they are used with caution. Obesity is associated with an increased riskof multiple health problems, including hypertension, type-2 Diabetes, obstructive sleepapnea , dyslipidemia ,non-alcoholic fatty liver disease, degenerative joint disease. Thusit is important for its identification, evaluation and treatment so that associatedcomorbities doesn’t occur.
Worldwide obesity has nearly tripled since 1975. In 2016, more than 1.9 billion adults, 18years and older, were overweight. Of these over 650 million were obese. 39% of adults aged18 years and over were overweight in 2016, and 13% were obese. Most of the world’s
population live in countries where overweight and obesity kills more people thanunderweight. 39 million children under the age of 5 were overweight or obese in 2020.Over
340 million children and adolescents aged 5-19 were overweight or obese in 2016. Pharmacology of Ayurvedic treatment on Sthaulya based on dissolving the accumulated fat
by means of shoshana like sleshma-medohara ,ushna, trikshna aahara or drugs. Thedrugs which will replinsh or scrapes away the unwanted tissues (dhatus) and metabolicwastes (malas) is known as Lekhana. In Modern anti-hypercholesterolemia or anti-obesity like drugs are found to have
many adverse effects; hence it is the need of the hour to find an alternative drug in other
10
systems of medicine. Although a number of research works and studies have been done onthe treatment of Sthaulya (Obesity), still there is an intense need for the effective
management of this dreadful disease. In this view the study has been selected to establishanti-obesity drugs and having anti-hyperlipidemic activity by using the Haritaki(Terminaliachebula) (Roxb.) mentioned in Charak samhita under Santarpaneeya adhyaya and in Ashtanghridya under Dwividho opkramneeya adhyaya containing Sthaulyanashak
properties.Dhanvyas(Fagonia cretica{Linn.}) mentioned in Bhavprakash Nighantu havingmedovikarhar properties. |