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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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, â€žLashuna‟ is selected. An analysis of Lashuna in minimizing bone loss after age 40 in women is planned in the study.

 
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