| CTRI Number |
CTRI/2017/04/008407 [Registered on: 24/04/2017] Trial Registered Prospectively |
| Last Modified On: |
11/04/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARATIVE CLINICAL STUDY BETWEEN LASHUNA AND SHATAVARI IN MINIMIZING THE RISK OF POSTMENOPAUSAL OSTEOPOROSIS
|
|
Scientific Title of Study
|
COMPARATIVE CLINICAL STUDY BETWEEN LASHUNA AND SHATAVARI IN MINIMIZING THE RISK OF POSTMENOPAUSAL OSTEOPOROSIS
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
T R THANGA SELVA KUMARI |
| Designation |
MD SCHOLAR |
| Affiliation |
PARUL INSTITUTE OF AYURVEDA |
| Address |
PARUL INSTITUTE OF AYURVEDA
PARUL UNIVERSITY LIMDA WAGHODIYA PARUL INSTITUTE OF AYURVEDA
PARUL UNIVERSITY LIMDA WAGHODIYA Vadodara GUJARAT 391760 India |
| Phone |
9566535174 |
| Fax |
|
| Email |
selvanakshathra@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR MANSI MODI |
| Designation |
ASSITANT PROFESSOR |
| Affiliation |
Parul Institute Of Ayurveda |
| Address |
PARUL INSTITUTE OF AYURVEDA
PARUL UNIVERSITY LIMDA WAGHODIYA PARUL INSTITUTE OF AYURVEDA
PARUL UNIVERSITY LIMDA WAGHODIYA Vadodara GUJARAT 391760 India |
| Phone |
9979883317 |
| Fax |
|
| Email |
mansi.modi1@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR MANSI MODI |
| Designation |
ASSITANT PROFESSOR |
| Affiliation |
Parul Institute Of Ayurveda |
| Address |
PARUL INSTITUTE OF AYURVEDA
PARUL UNIVERSITY LIMDA WAGHODIYA PARUL INSTITUTE OF AYURVEDA
PARUL UNIVERSITY LIMDA WAGHODIYA Vadodara GUJARAT 391760 India |
| Phone |
9979883317 |
| Fax |
|
| Email |
mansi.modi1@gmail.com |
|
|
Source of Monetary or Material Support
|
| parul institute of ayurveda |
|
|
Primary Sponsor
|
| Name |
PARUL INSTITUTE OF AYURVEDA |
| Address |
parul institute of Ayurveda
parul university
limda wagodia391760 |
| Type of Sponsor |
Private 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 THANGA SELVA KUMARI |
Parul Ayurvedic Hospital |
Parul Insititute Of Ayurveda
Prasuthi Thantra and stree rogam OPD nO 104
Parul University
Limda Waghodia Vadodara GUJARAT |
9566535174
selvanakshathra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
postmenopausal osteoporosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lashuna tablets |
DOSE 6 gms per day in 3 divided
doses
DOSAGE FORM Tablet (500mg)
ANUPANA Milk
ROUTE Oral
duration 12 weeks |
| Comparator Agent |
Shatavari tablets |
6 gms per day in 3 divided
doses
Tablet (500mg)
Milk
Oral
duration 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
-Women of age group 40-60 years (Perimenopausal ,Menopausal, Post Menopausal age group) presentingoneormore risk factors ofdevelopingOsteoporosis.
-Clinical symptoms of Osteoporosisand laboratoryinvestigations showing boneloss.
-OsteoporoticfemalepatientswhoseBMD(t-score)isequaltoorlessthan-1willbe taken forthe present study.
- Patients diagnosedto beOsteoporoticon the basisof Singh‟sindex.
- Patients presenting with the classical symptoms of Asthi Kshaya vis-a-via
Osteoporosiswillbetaken for the study.
|
|
| ExclusionCriteria |
| Details |
BMD „t‟ –score above -1 will be excluded.
• Patients suffering from neoplasm of the bone will be excluded.
• Known cases of Diabetes mellitus, uncontrolled Hypertension, Thyrotoxicosis, Hyper Parathyroidism, Addison‟s disease, Paget‟s disease, Cushing‟s syndrome, Tuberculosis of the bone, Osteomalacia, and Chronic Renal, Hepatic and Cardiac Failure will be excluded.
• Rheumatoid Arthritis, Gouty Arthritis and any long-standing systemic disorder will be excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduces the post menopausal riskof osteoporosis |
reduces the post menopausal riskof osteoporosis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduce pain,improves the quality of life |
12 weeks |
|
|
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
24/04/2017 |
| 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="3" Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Postmenopausal Osteoporosis is a condition of major health importance because of its association with fractures. During the past decade , it has increasingly been substantial involvement of all medical sciences to develop and assess potential treatment. • Osteoporosis needs to be reassessed and scrutinized on the pathological and clinical parameters in Ayurvedic perspective along with its etiopathogenesis. So this study aims to throw light on the Ayurvedic concepts of Osteoporosis and its management. • Among the many examples that could be given to illustrate how quickly thoughts about a disorder can be translated rapidly into the clinical arena, perhaps Osteoporosis is one of the best. In one short decade, Osteoporosis has been transformed from a disorder considered an inevitable and irreversible consequence of aging to a disorder in which there in now factual therapeutic optimism. • The aim of medical therapy is to improve the bone density, maintain the bone health, and prevent fractures and other complications throughout the old age, so that the person is not crippled. In modern medicine, medical therapy of Osteoporosis is mainly aimed at preventing further bone loss, increasing and maintaining the bone mass and prevention of fractures. The present therapeutic scenario is calcium and vitamine D supplementation, use of calcitonin, hormone replacement therapy (HRT) in case of Post Menopausal Osteoporosis, use of certain drugs like biphosphonates and selective Estrogen Receptor Modulators (SERMs) etc. In the most recent advances use of anabolic steroids and strontium in Osteoporosis is being studied. • Hormonal replacement therapy, Biphosponates, SERMs and anabolic steroids are having their own adverse effects. Hormonal replacement therapy leads to increased risk of breast cancer, heart diseases, stroke, pulmonary embolism etc. Biphosphonates lead to gastro-intestinal tract related side effects and rapid IV infusion may lead to renal failure. SERMS lead to aggravation of the symptoms of the menopausal syndrome and swelling in legs apart from increasing the clotting tendency of blood. Calcium and vitamin-D supplements lead to gastro-intestinal disturbances like nausea, vomiting, poor appetite, flatulence etc.
• So, it is the need of the hour to carry extensive researches for finding efficient, economic, natural and safer formulations to manage Osteoporosis. Ayurveda has got many times tested formulations to treat diseases related to Asthi Dhatu. Keeping these principles in mind, the present study will be carried out to critically analyze the Ayurvedic perspective of Osteoporosis and its management through Lashuna. In present study, „Lashuna‟ is selected. An analysis of Lashuna in minimizing bone loss after age 40 in women is planned in the study. |