| 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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
PRE AND POST MENOPAUSAL WOMEN |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
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 · 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 – 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):286â€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] [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. |