| CTRI Number |
CTRI/2015/01/005474 [Registered on: 29/01/2015] Trial Registered Prospectively |
| Last Modified On: |
03/02/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
STUDY OF SOME AYURVEDIC MEDICINES IN THE TREATMENT OF ASTHI KSHAYA(DECREASE OF BONE TISSUE) |
Scientific Title of Study
Modification(s)
|
CLINICAL EVALUATION OF ABHADYA CHURNA AND
MUKTASUKTI BHASMA IN THE MANAGEMENT OF
OSTEOPENIA/OSTEOPOROSIS (ASTHI KSHAYA)
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrDipSundar Sahu |
| Designation |
Research Officer (Ayurveda) |
| Affiliation |
National Research Institute of Ayurvedic Drugs Development |
| Address |
National Research Institute of Ayurvedic Drugs Development
Bharatpur,Near kalinga studio,Bhubaneswar
HIG-90,DHARMAVIHAR,KHANDAGIRI,BHUBANESWAR
Khordha
ORISSA
751003,
India |
| Phone |
0674-2386702 |
| Fax |
0674-2386702 |
| Email |
drdssahu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrDipSundar Sahu |
| Designation |
Research Officer (Ayurveda) |
| Affiliation |
National Research Institute of Ayurvedic Drugs Development |
| Address |
National Research Institute of Ayurvedic Drugs Development
Bharatpur,Near kalinga studio,Bhubaneswar
HIG-90,DHARMAVIHAR,KHANDAGIRI,BHUBANESWAR
Khordha
ORISSA
751003,
India |
| Phone |
0674-2386702 |
| Fax |
0674-2386702 |
| Email |
drdssahu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrDipSundar Sahu |
| Designation |
Research Officer (Ayurveda) |
| Affiliation |
National Research Institute of Ayurvedic Drugs Development |
| Address |
National Research Institute of Ayurvedic Drugs Development
Bharatpur,Near kalinga studio,Bhubaneswar
HIG-90,DHARMAVIHAR,KHANDAGIRI,BHUBANESWAR
Khordha
ORISSA
751003,
India |
| Phone |
0674-2386702 |
| Fax |
0674-2386702 |
| Email |
drdssahu@gmail.com |
|
|
Source of Monetary or Material Support
|
| CENTRAL COUNCIL OF RESEARCH IN AYURVEDIC SCIENCE(dePTOF AYUSH,mINISTRY OH hEALTH 7 family welfare)Jaharlal NeheruBharatiya Chikitsha evam HomeopathyAnusandhan Bhawan,no61-65,Insitutional Area,Opp.D block,Janakpuri,new Delhi. |
|
|
Primary Sponsor
|
| Name |
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES |
| Address |
CENTRAL COUNCIL OF RESEARCH IN AYURVEDIC SCIENCE(dePTOF AYUSH,MINISTRY OH HEALTH 7 family welfare)Jaharlal NeheruBharatiya Chikitsha evam HomeopathyAnusandhan Bhawan,no61-65,Insitutional Area,Opp.D block,Janakpuri,new Delh |
| 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 |
| DRDIPSUNDAR SAHU |
OPD(ROOM NO-13) AND IPD(ROOM NO-52) OF NATIONAL RESEARCH INSTITUTE OF DRUGS DEVELOPMENT |
BHARATPUR,BHUBANESWAR,ORISSA
PIN-751009
Khordha
ORISSA |
0674-2386702
0674-2386702
drdssahu@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NRIADD ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients of either sex with in the age group of 40-65 years of agecomplaining of Bone pain and decaying BMD score between -1 to -3 on DEXA scan selected for trial perticipent.
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ABHADYA CHURNA AND MUKTA SUKTI 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 |
1 Patients of either sex between 40 to 65 years of age.
2 B.M.D -T. Score between ( -1 to -3 ) on DEXA Scan.
3 Willing and able to participate for 14 weeks.
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria
1. Patients who are consuming corticosteroids (more than 5mg/day of prednisolone or equivalent) for more than 3 months
2. Patients with history of Fragility Fracture.
3. Patients suffering from congenital disorders related to bone (Dysosteogenesis, Marfan’s Syndrome, etc.)
4. Patients with (Hypothyroidism and Hyperthyroidism, Hypoparathyroidism and Hyperparathyroidism, Cushing‘s syndrome)
5. Patients with unstable CV diseases
6. Patients suffering from Osteomalacia.
7. Patients suffering from Malabsorption syndrome
8. Patients who have undergone Organ transplantation
9. Patients who are immobilized since > 6 weeks
10. Patients with history of bone fracture in last 6 months.
11. Patients with concurrent serious cardiac, Hepatic Dysfunction (defined as AST and/or ALT > 3 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > 1.2mg/dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease.
12. Patients with Diabetes Mellitus
13. Alcoholics and/or drug abusers.
14. Patients with evidence of malignancy
15. Patients suffering from major systemic illness necessitating long term drug treatment/Auto-Immune disorders (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.)
16. Pregnant or lactating woman.
17. H/o hypersensitivity to any of the trial drugs or their ingredients
18. Patients who have completed participation in any other clinical trial during the past
Six (06) months.
19. Patients on calcium and Vitamin D supplementation.
20. Patients with history of Urolithiasis.
21. Known cases of Paget’s disease of bone
22. Any other condition which the investigator thinks may jeopardize the study.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in Serum – Osteocalcin level from Baseline to end of study
|
With in 12 weeks of study period we can observe the change of BMD tscore,Change in Bone specific alkaline Phosphatase and change in Quality of life index. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Change in Quality of Life index (QUALEFFO-41)
• Change in Bone Specific Alkaline Phosphatase
|
Total Study Period 24 months
Washout (if required) 2 weeks
Recruitment 14 months
Treatment Period 12 weeks
Follow-Up Period 2 weeks
Statistical Analysis 3 months
|
|
|
Target Sample Size
|
Total Sample Size="65"
Sample Size from India="65"
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)
|
01/07/2015 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
"NONE YET" |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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.
|