| CTRI Number |
CTRI/2019/08/020840 [Registered on: 22/08/2019] Trial Registered Prospectively |
| Last Modified On: |
01/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical Study to evaluate efficacy of Ayurvedic medicated enema with ayurvedic preparation in the management of osteoporosis |
|
Scientific Title of Study
|
A randomised controlled clinical study to evaluate the efficacy of Panchatikta ksheera basti with ayurvedic preparation in the management of Asthikshaya with respect to Osteopenia / osteoporosis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Varghese Jibi Thankachan |
| Designation |
Associate Professor |
| Affiliation |
Dr D Y Patil College of Ayurveda and Research Centre |
| Address |
Dr D Y Patil College of Ayurveda and Research Centre
Pune
MAHARASHTRA
411018
India |
| Phone |
8983478062 |
| Fax |
|
| Email |
vjayu82@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Varghese Jibi Thankachan |
| Designation |
Associate Professor |
| Affiliation |
Dr D Y Patil College of Ayurveda and Research Centre |
| Address |
Dr D Y Patil College of Ayurveda and Research Centre
Pune
MAHARASHTRA
411018
India |
| Phone |
8983478062 |
| Fax |
|
| Email |
vjayu82@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Varghese Jibi Thankachan |
| Designation |
Associate Professor |
| Affiliation |
Dr D Y Patil College of Ayurveda and Research Centre |
| Address |
Dr D Y Patil College of Ayurveda and Research Centre
Pune
MAHARASHTRA
411018
India |
| Phone |
8983478062 |
| Fax |
|
| Email |
vjayu82@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil University
Pimpri - Pune- 18 |
|
|
Primary Sponsor
|
| Name |
Dr D Y Patil University |
| Address |
Sant Tukaramnagar
Pimpri - pune -18 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| nil |
nil |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Varghese Jibi |
Dr D Y Patil College of Ayurved & Research Center |
Sant Tukaram nagar
pimpri pune 18
Pune
MAHARASHTRA |
8983478062
vjayu82@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
oral |
Shelcal 500mg once daily for 30 days. |
| Intervention |
Rectal and oral route |
Panchatikhta Ksheera basti 300ml rectally for 30 days along with Tablet pravalpanchamruta 250 mg twice for 30 days |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with classical sign and symptoms of of asthikshaya like asthishula, toda, sandhi shaithilya, kesha, loma, nakha, danta vikara and patana, daurbalya, rukshata etc.
2. Osteopenic /Osteoporotic patients of either gender whose BMD (t score) is equal to or less than -1 |
|
| ExclusionCriteria |
| Details |
1.Patients suffering from neoplasm of bone.
2.Known case of Diabetes Mellitus, Thyrotoxicosis, Hyper Parathyroidism, Addison’s disease, Paget’s disease, Cushing’s syndrome, Tuberculosis of bone , Osteomalacia, Chronic renal, Hepatic, cardiac failure
3.Rheumatoid Arthritis, Gouty Arthritis and any other long standing systemic disorders
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in functional and physical activities of the patients with improved daily lifestyle |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in their daily lifestyle |
30 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "26"
Final Enrollment numbers achieved (India)="26" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
22/08/2019 |
| Date of Study Completion (India) |
11/06/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is undertaken to check the role of Panchatikta ksheera basti and ayurvedic preparation in the management of the disease condition of Asthikshaya ( osteoporosis) with pathological investigations before and after. The total duration of the study is 30 days. Enrollment of the patients will be done after CTRI registration
The Total no of 30 Patients enrolled in the study . Group A was administered with Panchatikta Ksheera Basti and Praval Panchamruta 250 mg BD for 30 days with initial deepana -pachana drugs for 3 days. Out of which 3 patients were considered dropout as they discontinued the follow up. Group B was given with Organic Calcium Supplement+D3 orally for 30 days. 1 patient was considered dropout in Group B due to irregular follow up. Total 26 patients completed the study The results statistically showed better results in Group A than in Group B in some parameters. |