| CTRI Number |
CTRI/2015/07/006044 [Registered on: 22/07/2015] Trial Registered Retrospectively |
| Last Modified On: |
22/09/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Vayasthapana Gana and Rasayanakalpa Vati on Menopausal syndrome |
|
Scientific Title of Study
|
A clinical study on menopausal syndrome and its management by VayasthapanaGana and Rasayanakalpa vati |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krutika Chaudhari |
| Designation |
PG student , SRPT Department |
| Affiliation |
Institute for Postgraduate Training and Research in Ayurveda |
| Address |
Department of Stree Roga and Prasooti Tantra, Institute for Postgraduate Teaching and Research in Ayurveda, GAU GUJARAT, India
Department of Stree Roga and Prasooti Tantra, Institute for Postgraduate Teaching and Research in Ayurveda, GAU GUJARAT, India
Jamnagar
GUJARAT
361008
India |
| Phone |
9429012309 |
| Fax |
|
| Email |
chaudhari_krutika88@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof M S Baghel |
| Designation |
Director of Institute for Post Graduate Teaching and Research Ayurveda |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurveda University
Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurveda University
Jamnagar
GUJARAT
361008
India |
| Phone |
9427207964 |
| Fax |
|
| Email |
baghelayu@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof L P dei |
| Designation |
Professor and HOD of Stree Roga and Prasooti tantra Department |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurveda University Jamnagar
Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurveda University Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9228198366 |
| Fax |
|
| Email |
deilaxmipriya@yahoo.com |
|
|
Source of Monetary or Material Support
|
| PHARMACY OF GUJARAT AYURVED UNIVERSITY JAMNAGAR |
|
|
Primary Sponsor
|
| Name |
INSTITUTE FOR POST GRADUATE TRAINING AND RESEARCH IN AYURVEDA |
| Address |
IPGT & RA,GUJARAT AYURVED UNIVERSITY,JAMNAGAR,GUJARAT. |
| 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 Krutika Chaudhari |
Institute of postgraduate teaching and research in ayurveda |
OPD no 8 Dept of
SRPT IPGT RA
Jamnagar
GUJARAT
Jamnagar
GUJARAT |
9429012309
chaudhari_krutika88@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee institute of post graduate teaching and research in ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients who suffering from Menopausal syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A-VayasthapanaGana Ghanavati |
Group A-Dose-2 tablets(500mg)BD with milk for 60 days |
| Comparator Agent |
Group B- rasayanakalpa Vati |
Group B-Dose 5 tablets(500mg)BD with milk for 60 days |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Amenorrhoea at least for 12 months or more.
Kupperman Menopausal Index Score ≥ 15
FSH ≥ 20 IU/L
Thickness of endometrium ≤ 5 mm by USG finding.
|
|
| ExclusionCriteria |
| Details |
Age below 40 years and age more than 55 years.
Women with uncontrolled medical conditions e.g. Hypertension, Heart disease, Diabetes mellitus, Cancer.
Who had the H/O Hormone replacement therapy (HRT).
Women having H/O excessive and/or irregular bleeding per vaginally. Established case of mental illness.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO EVALUATE AND COMPARE THE EFFICACY OF BOTH TRIAL DRUGS IN MENOPAUSAL SYNDROME |
2 months in both groups |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To improve the quality of life of menopausal women |
2 months in both groups |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
13/03/2014 |
| Date of Study Completion (India) |
27/02/2015 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
My study is on Menopausal syndrome.Drugs used for study are Vayasthapangana Ghanvati and RasayankalpaVati.vayasthapanagana Ghanavati is trial drug and rasayankalpaVati is proved drug for Menopausal syndrome.Both drugs given to the female patients age group between 40 to 50 years for 2 month by random sampaling method by toss and coin is done..Before study started each patient is gone for investigation process.Ultrasound done for endometrium thickness.routine heamatological and urine routine and microscopic examination done.Hormonal essay is also done.serum follical stimulating hormone and serum oestradiol are done.if patient fulfill all the above criteria then medicine is given for two month.Vayasthapanaganaghanavti 2 tablets(500mg) bd are given with milk before empty stomach.Rasayankalpavati 5 tablets(500mg) bd are given with milk before empty stomach.follow up is taken for one month of each patient.
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