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CTRI Number  CTRI/2024/04/066033 [Registered on: 19/04/2024] Trial Registered Prospectively
Last Modified On: 09/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Study of Asthi in pre and post menopausal women with special reference to Bone Minral Density  
Scientific Title of Study   An Analytical Cross-Sectional Study of Asthi Dhatu in pre and post menopausal women with special reference to bone mineral density  
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. Rubina Bano  
Designation  MD Scholar  
Affiliation   
Address  Department of Kriya Sharir NIADU Jaipur
ROOM NO 217 in Department of Kriya Sharir and opd no 3NIADU Jaipur
Jaipur
RAJASTHAN
302002
India 
Phone  8949067372  
Fax    
Email  rubinakdl06@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR Mahendra Prsad  
Designation  Associate Professor  
Affiliation  National Institute of Ayurveda Deemed to be University Jaipur  
Address  Department of kriya Sharir NIADU Jaipur Rajsthan
room no 234 in Department of kriya Sharir NIADU , Jaipur Rajsthan
Jaipur
RAJASTHAN
302002
India 
Phone  9887315717  
Fax    
Email  mprasadmahendra5@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR Poonam Choudhary  
Designation  Assistant Professor  
Affiliation  National Institute of Ayurveda Deemed to be University Jaipur  
Address  Department of Prasuti Tantra and Srti Roga
OPD NO 26 AND 27 Department of Prasuti Tantra and Srti Roga
Jaipur
RAJASTHAN
302002
India 
Phone  9352311106  
Fax    
Email  poonam.18veena@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda Demeed to be university Jaipur  
 
Primary Sponsor  
Name  National Institute of Ayurveda Deemed to be University Jaipur 
Address  National Institute of Ayurveda Deemed to be University Jorawar Singh Gate Amer Road Jaipur 302002  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NOT APPLICABLE   NOT APPLICABLE  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rubina Bano  National Institute of Ayurveda Deemed to be University Jaipur   National Institute of Ayurveda Deemed to be University Jorawar Singh Gate Amer Road Jaipur 302002
Jaipur
RAJASTHAN 
8949067372

rubinakdl06@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
Institutional Ethics Committee National Institute of Ayurveda Deemed to be university Jaipur Rajasthan   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  PRE AND POST MENOPAUSAL WOMEN  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  Women in the age group of 40-55 years
Women in the age group of 40-55 years who are having regular and adequate menstruation will be considered as premenopausal group
For postmenopausal group, Only those women will be included who did not had menstrual periods for 1 year.
 
 
ExclusionCriteria 
Details  K/C/O any systemic disorders (Cardiac disease, hypertension, hyperthyroidism, hypothyroidism, diabetes mellitus.Etc)
Women those who are already diagnosed with malignancy.
Women with H/o any obstetric surgery like hysterectomy and ovarian surgery
Subject on immunosuppressive drugs or steroidal therapy.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessment of the Bone Mineral Density in premenopausal and postmenopausal women  1.5 years  
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of the status of Asthi Dhatu Sarata in premenopausal women and postmenopausal women  1.5 yers  
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   18/06/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

NEED OF STUDY:

Decreased Bone Mineral Density (BMD) is a major consequence that is associated with feeble, frail and fractured bones .[i]Osteoporosis and its worst outcomes such as fractures and chronic pain are common in both genders, however, women are more vulnerable, accounting for 70–80 percent of all traumas including hip, spine and wrist fractures[ii]. This prevalence increases further in postmenopausal women because of reduced estrogen levels resulting in accelerated loss of bone mass [iii].According to WHO, 30 % of postmenopausal women suffer from osteoporosis. Estrogen deficiency play an important role in development of osteoporosis. So we can say that  postmenopusal  women tend to loose bone      at a rapid rate compared to younger age . [iv]

According to WHO diagnostic classification of osteoporosis is defined by BMD. Many evolving clinical factors that influence the risk of osteoporotic changes are  poor exposure of sunlight, nutritional factors specially calcium deficiency, vit D deficiency, postmenopausal hormone mediated metabolic elements and low bone mineral density. The prevalence of osteoporosis is observed four time more common in women than in men.

DXA has become the most widely used method to assess bone mineral density. Important features of DXA that made it popular were easy of use, high precision, and low radiation exposure to the patient. The noninvasive measurement of bone mass in the rat using DXA has proved to be accurate and precise, and DXA has become a primary search tool for the assessment of bone mineral density in an experimental environment. These developments the have inspired a multitude of clinical studies with serial bone mineral density assessment using DXA measurements assess the efficacy of the study medication in preserving or gaining bone mass.[v]

The present study is to assess the status of Asthi Dhatu Sarata in premenopausal stage and postmenopausal stage according to Ayurvedic prespective with special reference to BMD.

AIM:

To assess the status of Asthi Dhatu Sarata in premenopausal Group in comparison to postmenopausal  group  with  special reference to Bone Mineral Density.

 

OBJECTIVES:

Ø  To study the physiology of Asthi Dhatu Sarata

Ø  To study the physiology of Rajah

Ø To assess the Asthi Dhatu Sarata and Bone Mineral Density in  Pre and Post Menopausal women

Ø  To compare the Bone mineral density status in  premenopusal group and post menopausal     group

HYPOTHESIS:

NULL HYPOTHESIS (H0):

There is no relation in status of Asthi Dhatu Sarata  in premenopausal group and post menopausal  group With Special Reference to Bone Mineral Density.

 

ALTERNATIVE HYPOTHESIS (H1):

There is relation in status of Asthi Dhatu Sarata  in premenopausal group and  postmenopausal group with special reference to Bone Mineral Density .

 

OUTCOME:

PRIMARY OUTCOME:

 Assessment of the Bone Mineral Density in premenopausal and postmenopausal women

 

SECONDARY OUTCOME:

Assessment  of the status of Asthi Dhatu  Sarata in premenopausal women and postmenopausal women

METHODOLOGY:


·       Study Setting:        In and around of NIA(DU), Jaipur.,

·       Study Population: IPD and OPD patient in NIA(DU) hospital,

·       Period of study:     One and half years

·       Sampling:  Quota sampling.

·       Sample Size– 150 subjects will be  non randomly selected and divided into 2 groups; each group  will be having 75 subjects.

 Group A -   75 Premenopausal women selected for this study.

 Group B -   75 Postmenopausal women Selected  for this study.

Site of BMD Scan  â€“ Left hip joint bone in both groups .

ASSESSMENT CRITERIA:

Subjective Criteria:

1.     Asthi Dhatu Sarata[i]

Objective Criteria:

1.Assessment criteria based on BMD .

WHO definitions of osteoporosis based on BMD [i]



[i] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5335887/table/t4-ejr-4-1-46/?report=objectonly



[i] Gunawat CP, Singh G, Patwardhan K, Gehlot S. Weighted mean: A possible method to express overall Dhatu Sarata. J Ayurveda Integr Med. 2015;6(4):286‐289. doi:10.4103/0975-9476.172386



[i] Weaver C.M., Gordon C.M., Janz K.F., Kalkwarf H.J., Lappe J.M., Lewis R., O’Karma M., Wallace T.C., Zemel B.S. The National Osteoporosis Foundation’s position statement on peak bone mass development and lifestyle factors: A systematic review and implementation recommendations. Osteoporos. Int. 2016;27:1281-1386. doi: 10.1007/s00198-015-3440-3. [PMC free article] [PubMed] [CrossRef] [Google Scholar]

[ii] Johnell O., Kanis J.A. An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporos. Int. 2006;17:1726-1733. doi: 10.1007/s00198-006-0172-4. [PubMed] [CrossRef] [Google scholar}

[iii] Kanis J.A. Assessment of fracture risk and its application to screening for postmenopausal osteoporosis: Synopsis of a WHO report. Osteoporos. Int. 1994;4:368-381. doi: 10.1007/BF01622200. [PubMed] [CrossRef] [Google Scholar]

[iv] https://www.ncbi.nlm.ih.gov/pmc/articles/PMC8910053/ text xil  https://www.sciencedirect.com/science/article/pii/S1028455921001388

[v] Hagiwara S, Lane N, Engelke K, et al: Precision and accuracy for rat whole body and femur bone mineral determination with dual x-ray absorptiometry. Bone Miner 22:57, 1993.

 
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