| CTRI Number |
CTRI/2024/11/076247 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
04/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy
Other (Specify) [Experimental Study Pretest and Posttest Design] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Homoeopathic Medicines in Management of Obesity with PCOD |
|
Scientific Title of Study
|
Efficacy of Individualized Homoeopathic Medicines in Management of Obesity with PCOD A Clinical Study |
| 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 Neelam Tiwari |
| Designation |
Assistant Professor, Practice of Medicine, PhD Scholar |
| Affiliation |
Rajasthan Vidyapeeth Homoeopathic Medical College and Hospital, Dabok, Udaipur |
| Address |
Department of Practice of Medicine, UG Block, First Floor, Rajasthan Vidyapeeth Homoeopathic Medical College and Hospital, Dabok, Udaipur
Udaipur
RAJASTHAN
313022
India |
| Phone |
9784926737 |
| Fax |
|
| Email |
drneelamtiwari0721@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Ashok Yadav |
| Designation |
HOD, Practice of Medicine, Guide |
| Affiliation |
Dr. M. P. K. Homoeopathic Medical College, Hospital and Research Center, Jaipur |
| Address |
Department of Practice of Medicine, PG Block, Ground Floor, Homoeopathy University, plot No. 10, 11, 12 Saipura- Sanganer, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302029
India |
| Phone |
9829053664 |
| Fax |
|
| Email |
drashok112@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Ashok Yadav |
| Designation |
HOD, Practice of Medicine, Guide |
| Affiliation |
Dr. M. P. K. Homoeopathic Medical College, Hospital and Research Center, Jaipur |
| Address |
Department of Practice of Medicine, PG Block, Ground Floor, Homoeopathy University, plot No. 10, 11, 12 Saipura- Sanganer, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302029
India |
| Phone |
9829053664 |
| Fax |
|
| Email |
drashok112@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Neelam Homoeopathic Clinic, House no. 5, Mahaveer Shree ji Nagar, Raghunathpura, Udaipur, Rajasthan, India, Pincode 313001 |
| Rajasthan Vidyapeeth Homoeopathic Medical College and Hospital, Dabok, Udaipur, Rajasthan, India, pincode 313022 |
|
|
Primary Sponsor
|
| Name |
Rajasthan Vidyapeeth Homoeopathic Medical College and Hospital Dabok Udaipur |
| Address |
Rajasthan Vidyapeeth Homoeopathic Medical College and Hospital, Dabok, Udaipur, (Rajasthan) India, Pincode 313022 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Neelam Homoeopathic Clinic |
5, Mahaveer Shree ji Nagar, Raghunathpura, Udaipur |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nivedita Pattanaik |
Rajasthan Vidyapeeth Homoeopathic Medical College and Hospital |
Rajasthan Vidyapeeth Homoeopathic Medical College and Hospital, Dabok, Udaipur, Pincode- 313022
Udaipur
RAJASTHAN |
8769746883
niveditapattanaik11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Homoeopathy University, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E668||Other obesity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Constitutional Homoeopathic Medicines like Calcarea Carbonica, Lycopodium, Ammonium Mur, Ammonium carb, Natrum Mur, Antimonium crudum, Pulsatilla, Sepia |
Medicine will be given in 30C, 200C or 1M potency as per the prescribing totality
Auxillary management will be advised as per need of the cases |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Age group 18 to 35 yrs
Obese females suffering from PCOD
Patients having symptoms affected by lifestyle modification, irrespective of socio-economic status and occupation
BMI more than 25 kg/m2
Among urban area
Diagnosed case of PCOD |
|
| ExclusionCriteria |
| Details |
Patient having obesity due to any other disorders (Cushing syndrome, Nephrotic syndrome, DM, HTN, Thyroid) will be excluded by clinical examination
Case with depression and anxiety
Case with systemic disorders and complications
Pt. not able to fill the criteria of study
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in weight with feeling of physical well-being, increase in physical activities |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any changes in PCOD related complaints physical as well as mental symptoms |
12 months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/11/2024 |
| 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
|
Screening PCOS cases will be identified from target population As per the eligibility criteria, Simple Random sampling will be done Informed consent will be taken 30 selected cases will be evaluated for the parameters weight, height, BMI, S/O check-list After detailed case, similimum will be prescribed in Experimental group (30 cases) 3, 6, 9 and 12 months follow up will be maintained Conclusion will drawn
Decrease in weight with feeling of physical well-being, increase in physical activities and any changes in PCOD complaints will recorded
|