| CTRI Number |
CTRI/2017/05/008614 [Registered on: 22/05/2017] Trial Registered Retrospectively |
| Last Modified On: |
02/06/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
abhadya chura and mukta bhasma in the management of Ashthi Kshaya. |
|
Scientific Title of Study
|
clinical evaluation of abhadya chura and mukta bhasma in the management of Osteopenia/osteoporosis(Ashthi Kshaya) |
| 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 Panda |
| Designation |
Research Officer (Ayurveda) |
| Affiliation |
CCRAS, New Delhi |
| Address |
Central Ayurveda Research Institute of Hepatobiliary diseases ,
Deaprtment of Ayurveda , Bharatpur, Near Kalinga studio, Bhubaneswar , Odisha - unit of CCRAS, M/O AYUSH, GOI.
Central Ayurveda Research Institute of Hepatobiliary diseases ,
Bharatpur, Near Kalinga studio, Bhubaneswar , Odisha
unit of CCRAS, M/O AYUSH, GOI.
Khordha
ORISSA
751003
India |
| Phone |
9434631670 |
| Fax |
09434631670 |
| Email |
akpanda_06@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Kumar Panda |
| Designation |
Research Officer (Ayurveda) |
| Affiliation |
CCRAS, New Delhi |
| Address |
Central Ayurveda Research Institute of Hepatobiliary diseases , Deaprtment of Ayurveda , Room no-06, Bharatpur, Near Kalinga studio, Bhubaneswar , Odisha - unit of CCRAS, M/O AYUSH, GOI.
Central Ayurveda Research Institute of Hepatobiliary diseases ,
Bharatpur, Near Kalinga studio, Bhubaneswar , Odisha
unit of CCRAS, M/O AYUSH, GOI.
Khordha
ORISSA
751003
India |
| Phone |
9434631670 |
| Fax |
09434631670 |
| Email |
akpanda_06@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Kumar Panda |
| Designation |
Research Officer (Ayurveda) |
| Affiliation |
CCRAS, New Delhi |
| Address |
Central Ayurveda Research Institute of Hepatobiliary diseases , Room no -06 Bharatpur, Near Kalinga studio, Bhubaneswar , Odisha - unit of CCRAS, M/O AYUSH, GOI.
Central Ayurveda Research Institute of Hepatobiliary diseases ,
Bharatpur, Near Kalinga studio, Bhubaneswar , Odisha
unit of CCRAS, M/O AYUSH, GOI.
Khordha
ORISSA
751003
India |
| Phone |
9434631670 |
| Fax |
09434631670 |
| Email |
akpanda_06@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| CCRAS,
Institutional Area, Janakpuri, NewDelhi
|
|
|
Primary Sponsor
|
| Name |
CCRAS New Delhi |
| Address |
Central Council for Research in Ayurvedic Sciences
Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhavan
No.61-65, Institutional Area, Opp. D Block, Janakpuri,
New Delhi - 110058 ( India )
Telephone (EPABX): 91-011-28525862/28525897/28525852
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Kumar Panda |
CARIHD, Bhubaneswar |
Central Ayurveda Research Institute of Hepatobiliary diseases hospital , Bharatpur, Near Kalinga studio, Bhubaneswar , Odisha
Khordha
ORISSA |
9434631670
9434631670
akpanda_06@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethic committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M199||Osteoarthritis, unspecified site. Ayurveda Condition: ASTHIGATAVATAH, patients of either sex inbetween 45 to 65 years. BMDT score -1, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Abhadya Churna &
MuktaSukti Bhasma |
Abhadya Churna (AFI -Part III-Vol.- I Pg.123-124). Dose 5 gm (1 Sachet of 5gm) twice daily Dosage form 30 Sachet of 150 gms Oral Route of Administration Oral Time of Administration Twice a day after food Anupana Lukewarm Water Packing form A Hard cartoon Box of 150 gm (containing 30 Sachet of 150 gms each) Duration of therapy 12 weeks MuktaSukti Bhasma ((AFI-PartI--Page.238-239). Dose 250 mg twice daily Dosage form Capsule of 250 mg Route of Administration Oral Time of Administration Twice a day after food Anupana Lukewarm Water Packing form A plastic jar of 7.5 gm(Containing 30 capsules of 250 mg each Duration of therapy 12 weeks |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
BMD T score less than -1 |
|
| ExclusionCriteria |
| Details |
fragidity of bone, endocrine dis0rders,patients having poorly controlled hypertension, serum calcium less than 2.6 and more than 10.5 mg/dl |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change in quality of life index, |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| change BMD Tscore, Bone specific alkaline phospatase change |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "65"
Final Enrollment numbers achieved (India)="65" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/02/2017 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Asthi kshaya is a condition in which there is decrease in the Asthi dhatu (Bone tissue) leading to many undesirable effects. It can be compared with Osteoporosis in which there is decrease in the Bone Mineral Density (BMD) leading to increased risk of fractures. The Primary aim of the study is to stop further loss of mineral density of bone and to development of ossification through the compound formulations projected, since which has probable effect of Osteogenic effect which can be experimented in the different studies. MuktaSukti Bhasma (Ref- AFI Part-I Page-238- 239) has been experimented is natural source of rich calcium widely used in Traditional system of Indian medicine as a supplement in the treatment of Bone metabolic disorder associated with calcium deficiency.(Ref.Pharmacological Research Volume 48,Issue-6,December 2003,Pages 593-599).Sudha barga compounds having therapeutically rich in calcium (Ref-International journal of Pharmacy ISSN-2230-8407).However the compound effect of Abhadya churna has not been taken into study neither or not experimented so far. But it has been indicated for Majjagata Vata(Bone marrow related) disorder. (Ref- AFI –Part-III ,VOl-1but the all the individual ingredients of Abhadya churna have already been proven to be efficacious in bone marrow related disorder or improvement of bone health.Abhadya churna content The Hypothesis of evaluating the Osteogenic effect from both the combinations, it has been decided to take a study of both the combined formulations i.e. Abhadya Churna and Prabal Bhasma in selected cases of Osteoporosis/Osteopenia (Asthi Kshaya). The results will be assessed as per the standard guidelines.
It is a prospective clinical trial of classical Ayurveda medicine used in osteopenia since long. It is effort to create evidence of Ayurveda medicine and access the safety and efficacy of trial drug in osteopenia . The project was funded by CCRAS. Special CRF was prepared and NABH accredited laboratory selected to conduct the test. Both subjective and objective parameters will compared with base line and after 12 weeks of treatment. The primary objective to note the quality of life index(QUALEFF0-41)
|