| CTRI Number |
CTRI/2021/01/030574 [Registered on: 19/01/2021] Trial Registered Prospectively |
| Last Modified On: |
19/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management Of Asthi Dhatu Kshaya Vikara (Osteoporosis) |
|
Scientific Title of Study
|
Pharmaco-therapeutic study of ‘Vanadrakshadi yog’ (Kalpita
yog) in the management of ‘Asthi dhatu kshay vikara’ w.s.r. to
Osteoporosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashok Kumar Mittal |
| Designation |
PG scholar |
| Affiliation |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University College Jodhpur |
| Address |
PG Deptt of Dravyaguna vigyan, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University College
Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9929628888 |
| Fax |
|
| Email |
ashok70.mittal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr chandan singh |
| Designation |
Associate professor and HOD, PG Deptt of dravyaguna vigyan |
| Affiliation |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University College Jodhpur |
| Address |
PG Deptt of Dravyaguna vigyan, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University College
Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9950156020 |
| Fax |
|
| Email |
chandan_singh4@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Kumar Mittal |
| Designation |
PG scholar |
| Affiliation |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University College Jodhpur |
| Address |
PG Deptt of dravyaguna vigyan, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University College
Jodhpur
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University College
Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9929628888 |
| Fax |
|
| Email |
ashok70.mittal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
|
|
Primary Sponsor
|
| Name |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur |
| Address |
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University nagaur road karwad Jodhpur |
| Type of Sponsor |
Government 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 Ashok mittal |
DSRRAU jodhpur |
OPD number 13, UCA hospital, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Nagaur road, Karwad, Jodhpur
Jodhpur
RAJASTHAN |
9929628888
ashok70.mittal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committe, DSRRAU, Jodhpur |
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. Ayurveda Condition: Asthi dhatu kshay vikara, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
asthishrinkhla |
20 patients will be given asthishrinkhla capsulesin dose of 500mg orally twice daily for 84 days |
| Intervention |
Vanadrakshadi yog |
20 patients will be given Vandrakshadi yog (kalpita)
capsules in dose of 500mg orally twice daily for 84 days |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Well diagnosed and confirm patient of asthi dhatu kshaya vikara (Osteoporosis)
Patients age above 35 years to 65 years
Osteopenic / osteoporotic patients of either sex who’s BMD (t score)
is equal to or less than -1.8
Patient who give written consent of agreement to voluntarily participate in the clinical study.
|
|
| ExclusionCriteria |
| Details |
Patient suffering from any veneral disease and diabetes
Patient suffering from osteoporosis due to genetical and inherited disorders.
Juvenile osteoporosis.
Pregnant ladies and severely anemic.
Osteoporosis due to hypogonadism.
In the patient suffering from Hepatitis, AIDS, Malignancies, Tuberculosis, Cardiac disorders.
Osteoporosis in the patient suffering from mental and acute infectious disorders.
All the patients who had known allergy or contraindication to any of the drug used in this study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in subjective and objective
parameters |
84 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of treatments in both
groups |
84 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3 |
|
Date of First Enrollment (India)
|
22/01/2021 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is open label parallel group trial to compare the efficacy of Vandrakshadi Yog and asthishrinkhala in the management of osteoporosis. In one group Vandrakshadi yog 500mg capsule with lukewarm water will be given twice a day after meal for 84 days. In another group 500mg of asthishrinkhla capsules of 500mg will be given twice a day with lukewarm water after meal for 84 days. |