| CTRI Number |
CTRI/2016/06/007052 [Registered on: 29/06/2016] Trial Registered Retrospectively |
| Last Modified On: |
02/03/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to evaluate the efficacy of Ashwagandhadi vati and Muktashuktadi vati in the treatment of Osteoporosis (Asthi kshaya) |
|
Scientific Title of Study
|
A study of osteoporosis w.s.r to asthi kshaya and its management by ashwagandhadi vati and mukta-shuktibhasmadi vati |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manisha Lakhi |
| Designation |
M.D Scholar |
| Affiliation |
|
| Address |
Dept.of Kayachikitsa, Institute for Post Graduate Teaching and Research in Ayurveda,
Gujarat Ayurved University, Jamnagar, GUJARAT
Jamnagar
GUJARAT
361008
India |
| Phone |
8347620562 |
| Fax |
|
| Email |
manishalakhi@live.nl |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alankruta Dave |
| Designation |
Associate professor incharge H.O.D Kayachikitsa |
| Affiliation |
|
| Address |
Dept.of Kayachikitsa, Institute for Post Graduate Teaching and Research in Ayurveda,
Gujarat Ayurved University, Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9824171817 |
| Fax |
|
| Email |
alankruta@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Alankruta Dave |
| Designation |
Associate professor incharge H.O.D Kayachikitsa |
| Affiliation |
|
| Address |
Dept.of Kayachikitsa, Institute for Post Graduate Teaching and Research in Ayurveda,
Gujarat Ayurved University, Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9824171817 |
| Fax |
|
| Email |
alankruta@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Teaching Hospital GAU Jamnagar |
|
|
Primary Sponsor
|
| Name |
Post Graduate Teaching Hospital GAU Jamnagar |
| Address |
Gujarat Ayurved University |
| 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 |
| DrManisha Lakhi |
OPD AND IPD kayachikitsa dept IPGT&RA |
dept of kayachikitsa
IPGTRA GAU
Jamnagar
GUJARAT |
8347620562
manishalakhi@live.nl |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Osteoporosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ashwagandhadi vati |
orally 1 tab(500mg) after meal twice a day with water for 8weeks follow up 4 weeks
|
| Comparator Agent |
Muktashuktibhasmadi vati |
orally 1 tab (500mg) before meal twice a day with water for 8 weeks follow up 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of Osteoporosis diagnosed by Bone Mineral Density test.
Patients willing to participate in the clinical trial.
Patients complaining of symptoms; joint pain, backache pain in the bones, which will be confirmed later by the BMD-test.
|
|
| ExclusionCriteria |
| Details |
Patients below 40 years of age
Patients above 70 years of age
Pregnant women and lactating women.
Patients associated with other systemic disorders.
Hyperparathyroidism
Patients who have undergone chemotherapy and radiotherapy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in the clinical symptoms of Osteoporosis like
Backache,
Joint pain,
Pain in the bones
|
8weeks and 4 weeks follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in the Bone mineral density test |
8weeks and 4 weeks follow up |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
14/08/2015 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Ayurveda refers Osteoporosis to Asthi Kshaya. Osteoporosis is a metabolic bone disorder. The meaning of osteoporosis is ’’porous bones’’ or ’’the brittleness of the bones due to increased porosity from loss of mineral substance’’ causing decrease in the bone tissue & leading to the increased risk of fractures. This disease is mentioned in our classics as well, the formulations of both of the drugs are not directly referred to the classics, but single drug wise it has been said that it is useful for this disorder. By experience of using this formulations it is found to be effective in patients with osteoporosis. The ingredients of Mukta-shukti bhasmadi vati will be :
1.Mukta-shukti bhasma; which supplements calcium(rasayana) to promote bone formation (asthi balya), muscle contraction & nerve conduction. (R.T.S.S.P.S.Part 1,pp. 196-8)
2.Amalaki; which is a source of vitamin C., an antioxidant (rasayana)that promotes regeneration of tissues (dhatu-vardhaka) and reinforces immunity (balya).(Bh.Pr.Ni.Harit.37-40.) 3.Abhrak bhasma; which is a bioavailability enhancer (yogavahi) that enhances the efficacy of other ingredients, and an antioxidant (rasayana),an antiaging (ayu-vardhaka) and an immunomodulator(bala vardhaka).(R.T.S.S.P.S.Part 1,ppt150-61. 4. Yashad; which is an antioxidant that promotes regeneration of tissues( dhatu-vardhaka) and modulates immunity( rasapinda-vikriti-nashaka) In the Ashwagandhadi vati the ingredients will be: 1.Ashwagandha;which is a widely used rasayana( antioxidant,anti-aging,and regenerative)in ayurveda.Bhav prakash describes it as kshaya-apaha(regenerative),rasayani(rejuvenating and antioxidant),balya(immunomodulating), and shotha-apaha (anti-inflammatory). All these actions indicate that it helps regeneration of degenerating tissues(including joint cartilage). Some of these actions have been confirmed by Mishra LC et al. 2.Shilajatu; which has been used as an excellent rasayana . Bhav prakash describes it as rasayana, kshaya hara and shotha-hara indicating its significant role in the degenerating tissues (including joint cartilage)(Bh.pR.nI.dHAT.78-82, 3.Mandukparni; Bhav-prakash describes mandukparni as ayushya(anti-aging),rasayani,shotha hara and asrajit(corrects micro-circulation) (Bh.Pr.Ni.Gud.278-81) 4.Dughdika;Bhav prakash describes it as ruksha(anti-obesity) and ushna(metabolic stimulant)both of which help in weight reduction quite often found in patients with osteo-arthritis. (Bh.Pr.Ni.Gu.275-76) Dose of both of the drugs will be 1 tab (500mg) twice a day after food with luke warm water for 8 weeks and follow up will be for 4 weeks. Moreover, no work has been carried out previously on Mukta-shuktibhasmadi vati or Ashwagandhadi vati in the management of Asthi kshaya. Therefore to breakdown etiopathogenesis of asthi kshaya following shaman yoga has been selected. |