| CTRI Number |
CTRI/2018/08/015295 [Registered on: 13/08/2018] Trial Registered Prospectively |
| Last Modified On: |
20/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of Asthikshaya with special reference to Osteoporosis by Panchatikta Ksheera Basti (Medicated Enema) and Shamanoushadhi (Internal Medication) |
|
Scientific Title of Study
|
COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF PANCHATIKTA KSHEERA BASTI WITH AND WITHOUT SHAMANOUSHADHI IN ASTHIKSHAYA 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 SANTOSH L YADAHALLI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Government Ayurvedic Medical College, Dhanwantari Road, Bangalore-560009 |
| Address |
DEPT OF PANCHAKARMA,
OPD BLOCK, ROOM NO - 05A
GOVT AYURVEDIC MEDICAL COLLEGE,
DHANWANTRI ROAD, BANGALORE-560009
Government Ayurvedic Medical College, Dhanwantari Road, Bangalore-560009
Bangalore
KARNATAKA
560009
India |
| Phone |
9902322355 |
| Fax |
|
| Email |
ayursantosh@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SANTOSH L YADAHALLI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Government Ayurvedic Medical College, Dhanwantari Road, Bangalore-560009 |
| Address |
DEPT OF PANCHAKARMA,
OPD BLOCK, ROOM NO - 05A
GOVT AYURVEDIC MEDICAL COLLEGE,
DHANWANTRI ROAD, BANGALORE-560009
Government Ayurvedic Medical College, Dhanwantari Road, Bangalore-560009
Bangalore
KARNATAKA
560009
India |
| Phone |
9902322355 |
| Fax |
|
| Email |
ayursantosh@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR SANTOSH L YADAHALLI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Government Ayurvedic Medical College, Dhanwantari Road, Bangalore-560009 |
| Address |
DEPT OF PANCHAKARMA,
OPD BLOCK, ROOM NO - 05A
GOVT AYURVEDIC MEDICAL COLLEGE,
DHANWANTRI ROAD, BANGALORE-560009
Government Ayurvedic Medical College, Dhanwantari Road, Bangalore-560009
Bangalore
KARNATAKA
560009
India |
| Phone |
9902322355 |
| Fax |
|
| Email |
ayursantosh@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi University of Health Sciences Karnataka, Bangalore |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi University of Health Sciences Karnataka Bangalore |
| Address |
4th T Block Jayanagar Bangalore |
| Type of Sponsor |
Other [Govt run Health University of Karnataka state] |
|
|
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 Santosh L Yadahalli |
Govt ayurvedic medical college |
DEPT OF PANCHAKARMA,
OPD BLOCK, ROOM NO - 05A
GOVT AYURVEDIC MEDICAL COLLEGE,
DHANWANTRI ROAD, BANGALORE-560009
Bangalore
KARNATAKA |
9902322355
ayursantosh@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, Govt Ayurvedic Medical College, Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Having Osteoporotic condition, (1) ICD-10 Condition:J454||Moderate persistent asthma. Ayurveda Condition: TAMAKASVASAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A - PanchatiktaKsheera Basti |
Panchatikta Ksheera Basti, 16 Bastis in 10 days in which 420ml of 6 Niruha Basti and 60ml of 10 Anuvasana Bastis. |
| Comparator Agent |
Group B - Panchatikta Ksheera Basti and Shamanoushadhi |
Panchatikta Ksheera Basti 16 Basti for 10days in which 6 Niruha Basti with 420ml each and 10 Anuvasana Basti with 60ml each. Shamanoushadhi with 2gm per day. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients fulfilling the diagnostic criteria.
2 Patients fit for Basti Karma.
3 Patients aged between 40-70 years.
|
|
| ExclusionCriteria |
| Details |
1 Patients with other systemic disorders like Diabetes, Cardiac Diseases and Renal diseases.
2 Pregnancy.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in subjective parameters
Change in objective parameters |
One and half year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in subjective parameters
Change in objective parameters |
Change in Subjective and objective parameters with change in BMD |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
15/01/2019 |
| 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
|
Not yet recommonded |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This project entitled “COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF PANCHATIKTA KSHEERA BASTI WITH AND WITHOUT SHAMANOUSHADHI IN ASTHIKSHAYA W.S.R. TO OSTEOPOROSIS†is aimed to prove the effectiveness of Panchatikta ksheerabasti in osteoporosis with the objective criterias like BMD and vit D3. According to commentator Arunadatta the substance having Snigdha and shoshana properties and produces kharatwa will be responsible for Asti vardhana as Asti is also khara by nature. But no substance is available that has both snigdha and shoshsna properties. So ksheera and grita which are snigdha in nature are advised to be used with the substances which are tikta and possess shoshana property. Hence it can be said that Tikta ksheera basti has ability to repair degeneration of bones and cartilage. When Shodhana therapy is followed by the shamanoushadhi it will be having additive effect. Kukkutanda twak bhasma as a natural supplement of calcium along with guduchi satva which is having tikta rara and anti arthritic property and arjuna churna which is having action on astidhatu are taken in combination and given with grita as anupana is useful in treating osteoporosis. Hypothesis: H1 1. There is no difference between the result obtained before and after treatment in each group. 2. There is no difference in result obtained between the groups. H2 1. There is difference between the result obtained before and after treatment in each group. 2. There is difference in result obtained between the groups. |