| CTRI Number |
CTRI/2024/12/078375 [Registered on: 20/12/2024] Trial Registered Prospectively |
| Last Modified On: |
17/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Yoga for bone |
|
Scientific Title of Study
|
Treating osteoporosis with yoga: Indias first clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ravi Sankaran |
| Designation |
Professor and HoD |
| Affiliation |
Amrita Hospital Kochi |
| Address |
room 11, Department of PMR Ponekkara Rd, P. O, Edappally, Kochi, Ernakulam, Kerala 682041
ravisankaran@aims.amrita.edu
room 11, Department of PMR Ponekkara Rd, P. O, Edappally, Kochi, Ernakulam, Kerala 682041
ravisankaran@aims.amrita.edu
Ernakulam
KERALA
682041
India |
| Phone |
02854841234 |
| Fax |
|
| Email |
drravismd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ravi Sankaran |
| Designation |
Professor and HoD |
| Affiliation |
Amrita Hospital Kochi |
| Address |
room 11, Department of PMR Ponekkara Rd, P. O, Edappally, Kochi, Ernakulam, Kerala 682041
ravisankaran@aims.amrita.edu
room 11, Department of PMR Ponekkara Rd, P. O, Edappally, Kochi, Ernakulam, Kerala 682041
ravisankaran@aims.amrita.edu
Ernakulam
KERALA
682041
India |
| Phone |
02854841234 |
| Fax |
|
| Email |
drravismd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ravi Sankaran |
| Designation |
Professor and HoD |
| Affiliation |
Amrita Hospital Kochi |
| Address |
room 11, Department of PMR Ponekkara Rd, P. O, Edappally, Kochi, Ernakulam, Kerala 682041
ravisankaran@aims.amrita.edu
room 11, Department of PMR Ponekkara Rd, P. O, Edappally, Kochi, Ernakulam, Kerala 682041
ravisankaran@aims.amrita.edu
Ernakulam
KERALA
682041
India |
| Phone |
02854841234 |
| Fax |
|
| Email |
drravismd@gmail.com |
|
|
Source of Monetary or Material Support
|
| room 11, Department of PMR Ponekkara Rd, P. O, Edappally, Kochi, Ernakulam, Kerala 682041
|
|
|
Primary Sponsor
|
| Name |
Ravi Sankaran |
| Address |
room 11, Department of PMR Ponekkara Rd, P. O, Edappally, Kochi, Ernakulam, Kerala 682041
|
| Type of Sponsor |
Other [n/a] |
|
|
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 |
| DrRavi Sankaran |
Amrita Hospitals, Kochi |
Ponekkara, AIMS (P.O.)
Ernakulam
KERALA |
02854841234
ravisankaran@aims.amrita.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee Amrita school of Medicine |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M810||Age-related osteoporosis without current pathological fracture, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Resistance band exercises |
Patient is being asked to perform set of exercises for their health condition |
| Intervention |
Yoga |
Specific yoga programme that avoid flexion exercises and is done in standing position |
|
|
Inclusion Criteria
|
| Age From |
55.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
DEXA scan at least one year prior to entry.
Normal serum values of:
TSH
PTH
CMP
ESR or CRP
Vitamin D 25 Hydroxyl
Vitamin D 1,25 Dihydroxyl
Serum Collagen 1B telopeptide or Urine NTX
|
|
| ExclusionCriteria |
| Details |
Neuromuscular, metabolic or endocrinological abnormalities, e.g., Guillaine-Barre, diabetes mellitus, Graves disease, cancer.
Physical disability preventing yoga practice.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| DEXA scan |
0 and at 24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compliance to medications and yoga interventions |
0 and at 24 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 4 |
|
Date of First Enrollment (India)
|
30/12/2024 |
| 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="3"
Months="0"
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
|
Background:
More than 10,000,000 Americans have osteoporosis; mor than 44 million have osteopenia. These 54,000,000 people were found in a country of 330,000,000 people, approximately 1/6 of the population. Extrapolating to the 8,000,000,000 people on our planet, and acknowledging the older and younger populations in Europe and China, and the younger average age in Africa, we may conclude that 1/6 of the world’s population: more than one billion people are affected by weakened bones.
Although vertebral fractures are by far the most frequent, occurring at the rate of every three seconds, hip fractures are the most serious. Fully 25% of people with these fractures will perish, and another 25% will be permanently chair-bound. The pain and subsequent disability after hip and femoral fractures is well-known.
Since the population of the world is aging, a worsening of the epidemiology here is nearly certain. A safe and inexpensive way to deal effectively with bone loss will relieve this serious public health issue. The following study, if successful, will do just that.
Objective:
To determine the extent to which basic nutritional supplementation and brief yoga sessions can reverse bone loss.
Methods:
The study will calculate changes in DEXA scan measurements from before starting the study to those seen at study entry, and compare them with changes in DEXA scan measurements made after two years in the study. The rate of change of bone mineral density (BMD) in the one or more years preceding study entry will be compared with the rate of change in BMD in the two years of study participation. The study will track both intervention and control patient with an on-line database that participants fill out weekly.
Each patient will first be randomized using random.org, and then will give a full history and have a selective physical exam, by a physician who does not know their randomized group. The participant will then be taught the appropriate yogic modality, given a 3-months’ dose of the appropriate tablets/capsule or placebo, and a log on for the on-line database.
Weekly classes for yoga will be given and attendance and level of participation noted.
Tri monthly visits to the endocrinologist or physiatrist are in order.
Statistics will involve t-tests, MANCOVA, and Bayesian methods.
|