| CTRI Number |
CTRI/2020/03/023874 [Registered on: 11/03/2020] Trial Registered Prospectively |
| Last Modified On: |
22/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study Effect of Ashwagandhadi Churnvati and Lakshadi Guggul in the management of Dhatukhsyajanya Sandhigatvat of Janu Sandhi |
|
Scientific Title of Study
|
“A Randomized controlled clinical trial to evaluate the efficacy of Ashwagandhadi Churnvati with Lakshadi Guggul in Dhatukhsyajanya Sandhigatvat of Janu Sandhi.†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dnyaneshwar Laxman Sawant |
| Designation |
PG Student |
| Affiliation |
PDEAs College Of Ayurved and Reasearch Center |
| Address |
PDEAs College Of Ayurved and Reasearch Center, Third floor, Kayachikitsa Department, Sec No. 25, Nigdi Pradhikaran, Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
8975362309 |
| Fax |
|
| Email |
sawantdnyaneshwar516@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Medha Mahesh Joshi |
| Designation |
Guide and HOD of Kayachikitsa Department |
| Affiliation |
PDEAs College Of Ayurved and Reasearch Center |
| Address |
PDEAs College Of Ayurved and Reasearch Center, Third floor, Kayachikitsa Department, Sec No. 25, Nigdi Pradhikaran, Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9881465798 |
| Fax |
|
| Email |
medhamaheshjoshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dnyaneshwar Laxman Sawant |
| Designation |
PG Student |
| Affiliation |
PDEAs College Of Ayurved and Reasearch Center |
| Address |
PDEAs College Of Ayurved and Reasearch Center, Third floor, Kayachikitsa Department, Sec No. 25, Nigdi Pradhikaran, Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
8975362309 |
| Fax |
|
| Email |
sawantdnyaneshwar516@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research center, Third floor, Kayachiktsa Department, Nigdi, Pradhikaran, Sector 25, pune 44 |
|
|
Primary Sponsor
|
| Name |
Principal PDEAs College of Ayurved and Research center |
| Address |
PDEAs College of Ayurved and Research center, Nigdi, Pradhikaran, Sector 25, pune 44 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dnyaneshwar Laxman Sawant |
Ayurved and Sterling Multispeciality Hospital |
Vitthal Rukmini road, Sector No 27, Nigdi Pradhikaran, pune 411044, Name of OPD-Kayachikitsa, OPD No. 117, Ground floor, Pune
Pune
MAHARASHTRA |
8975362309
sawantdnyaneshwar516@gmail.com |
|
|
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 |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ashwagandhadi churnvati 1 gm |
Ashwagandhadi churnvati is prepared by Vatikalpana and will be given orally 1 gm after meal twice a day with lukewarm water which includes follow up on every 15th day till 2 months. |
| Comparator Agent |
Lakshadiguggul 500 mg |
Lakshadi Gugguli is prepared by Vatikalpana and will be given orally 500 mg two tablets after meal twice a day with lukewarm water which includes follow up on every 15th day till 2 months. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1 patients diagnosed with Osteoarthritis(Dhatukhsyajanya sandhigatvat of Janusandhi)
2 age - 45 yrs to 75 yrs of age
3 Gender - Male and Female
4 Patients presenting with the classical signs and symptoms of Dhatukhsyajanya sandhigatvat janu Shula, janu Shotha, stambha, sparsha-asahyata, janu sandhi sphutana, aakunchanaprasarana vedana, vatapurnadrutisparsha
5 Patients without any Anatomical Deformity |
|
| ExclusionCriteria |
| Details |
1 Patients below 45 yrs and above 75 yrs of age.
2 patients with known case of uncontrolled diabetes, rheumatoid arthritis ,psoriatic arthritis, gouty arthritis, systemic lupus erythematosus (SLE), bone Tuberculosis, injuries and other serious systemic disorders .
3 Fracture of knee joint.
4 Direct and indirect infection of knee joint.
5 History of any surgical procedure of knee joint.
6 Any anatomical deformity.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate efficacy of Ashwagandhadi Churnvati 1 gm at Vyanodan Kal with Koshnajal for 2 months is as effective as Lakshadi Guggul 500mg-2tab at Vyanodan Kal with Koshnajal for 2 months in Dhatukhsyajanya sandhigatvat of Janu Sandhi. |
60 days with follow up on every 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To compare the efficacy of Ashwagandhadi churnvati
2 To compare the efficacy of Lakshadi guggul
3 To observe the adverse effect if any |
60 days |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
27/03/2020 |
| 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="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
|
Dhatukshayjanya Sandhigatvat is the
disease well known since vedic period.
Dhatukshayjanya Sandhigatvat which is
known to world as Osteoarthritis of Knee joint.
Dhatukshayjanya Sandhigatvat in Janu
sandhi is one of such chronic degenerative inflammatary disease which has a
great impact on quality of life of an individual. Different modalities of
treatment have been explained in Ayurveda to tackle the condition effectively.
In India 20 million peoples are
suffered from Osteoarthritis. The prevalence rate of Osteoarthritis in India is
28.7%. It is more common in women than in men but prevalence increases
dramatically with age.
Dhatukhsyajanya Sandhigatvat can be
correlated with Osteoarthritis on the basis of some common symptoms like Joint
pain, stiffness, decreased range of motion, oedema.
In Ayurveda, effective management is described in
various AyurvedicSamhitas. Ayurveda has the best medicines and treatment options
for Osteoarthritis. If these treatments can be started at the beginning of the
symptoms, the degeneration can be prevented.
Hence there is a need of a drug explained in VangsenSamhita
in Chikitsa adhay named as Ashwagandhadi Churnvati.
|