| CTRI Number |
CTRI/2024/07/071134 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
19/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of Asthisamhaaradi Yoga(Polyherbal capsule) in Bone mass of age group 30-60 years, for period of 60 days. |
|
Scientific Title of Study
|
An Interventional Study to Evaluate the Efficacy of
Asthisamhaaradi Yoga on 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 Ajay Kumar A |
| Designation |
PG Scholar |
| Affiliation |
Alvas Ayurveda Medical College and Hospital, Mudubidre |
| Address |
Department of Kriya Shareera
Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodubidire, Dakshina Kannada, Karnataka 574227, India.
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8660619370 |
| Fax |
|
| Email |
ajaikumarachar98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K N Rajashekhar |
| Designation |
Professor and HOD |
| Affiliation |
Alvas Ayurveda Medical College and Hospital, Mudubidre |
| Address |
Department of Kriya Shareera
Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodubidire, Dakshina Kannada, Karnataka 574227, India.
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9481511292 |
| Fax |
|
| Email |
drknraamc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Kumar A |
| Designation |
PG Scholar |
| Affiliation |
Alvas Ayurveda Medical College and Hospital, Mudubidre |
| Address |
Department of Kriya Shareera
Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodubidire, Dakshina Kannada, Karnataka 574227, India.
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8660619370 |
| Fax |
|
| Email |
ajaikumarachar98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kriya Shareera
Alvas Ayurveda Medical College and Hospital, Vidyagiri, Mudubidre, Dakshina Kannada, Karnataka 574227, India |
|
|
Primary Sponsor
|
| Name |
Dr Ajay Kumar A |
| Address |
Department of Kriya Shareera
Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodubidire, Dakshina Kannada, Karnataka 574227, India. |
| Type of Sponsor |
Other [Self] |
|
|
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 Ajay Kumar A |
Alvas Ayurveda Medical College and Hospital |
Department of Kriya Shareera
Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodubidire, Dakshina Kannada, Karnataka 574227, India.
Dakshina Kannada
KARNATAKA |
8660619370
ajaikumarachar98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Alvas Ayurveda Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M859||Disorder of bone density and structure, unspecified. Ayurveda Condition: ASTHIKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Asthisamhaaradi Yoga, Reference: Cakradatta, Bhagna Chikitsa, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Ushna jala), Additional Information: 2 Vati TID, each vati containing 500mg |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with age group of 30 to 60 years irrespective of gender.
Individuals with Quantitative calcaneal ultrasound T score ≤ -1 will be taken.
Willing and able to participate for 8 weeks. |
|
| ExclusionCriteria |
| Details |
Individuals with systemic illness and under regular medication.
Pregnant and lactating women.
Subjects having any other condition which directly or indirectly interferes the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of Asthisamhaaradi yoga in Bone mineral density |
70 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of Bone mineral density using Portable ultrasound bone densitometer |
70 days |
|
|
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 3 |
|
Date of First Enrollment (India)
|
31/07/2024 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
An interventional study
to evaluate the efficacy of asthisamhaaradi yoga on bone mineral density of age
group 30-60 years for a period of 60 days. Individuals will be selected from in
and around Mudubidri by using Portable ultrasound bone densitometer with T
score </= -1 will be taken. Bone mineral density will be evaluated before
and after the intervention with Asthisamhaaradi yoga for 60 days by using
Portable ultrasound bone densitometer. |