| CTRI Number |
CTRI/2018/01/011603 [Registered on: 30/01/2018] Trial Registered Prospectively |
| Last Modified On: |
27/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Treatment Of Janu Sandhigatvata With Panchatikta Guggulu And Agnikarma |
|
Scientific Title of Study
|
A comparative clinical study on agnikarma along with panchatikta guggulu in the management of janu sandhigatvata (osteorthritis of knee joint) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manisha Kapadiya |
| Designation |
Research Scholar |
| Affiliation |
Institute For Post Graduate Teaching And Research In Ayurveda |
| Address |
Department Of Shalya Tantra IPGT And RA Gujarat Ayurved University Jamnagar
Department Of Shalya Tantra IPGT and RA Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9974047713 |
| Fax |
|
| Email |
manisha.kapadiya15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Anup Thakur |
| Designation |
Head Of Department Of Panchakarma IPGT and RA |
| Affiliation |
Institute For Post Graduate Teaching And Research In Ayurveda |
| Address |
4th floor Department Of Panchakarma IPGT and RA GAU Jamnagar
4th floor Department Of Panchakarma IPGT and RA GAU Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9427776660 |
| Fax |
|
| Email |
anup_thakar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Anup Thakur |
| Designation |
Head Of Department Of Panchakarma IPGT and RA |
| Affiliation |
institute for post graduate teaching and research in ayurveda |
| Address |
4th floor Department Of Panchakarma IPGT and RA GAU Jamnagar
4th floor Department Of Panchakarma IPGT and RA GAU Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9427776660 |
| Fax |
|
| Email |
anup_thakar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| institute for post graduate teaching and research in Ayurveda Gujarat ayurved university Jamnagar Gujarat 361008 |
|
|
Primary Sponsor
|
| Name |
institute for post graduate training and research center |
| Address |
Gujarat ayurved university Jamnagar |
| 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 |
| Manisha Kapadiya |
IPGT and RA Hospital Jamnagar |
IPGT and RA Hospital,OPD no. 3
Shalya Department
Jamnagar
GUJARAT |
9974047713
manisha.kapadiya15@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 |
patient diagnosed with janu sandhigatvata, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
agnikarma with panchatikta guggulu |
in group A, patients will be treated with agnikarma 4 sittings in 1 month as well as panchatikta guggulu 500mg will be given 1 tablet three times a day for 1 month |
| Comparator Agent |
Agnikarma with placebo capsule |
group B, patients will be treated with agnikarma 4 sittings in 1 month as well as placebo capsule with wheat powder will be given 1 capsule three times a day for 30 days. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)patients suffering from janu sandhigatavata(osteoarthritis of knee joint)
2)patients betweeb the age group 35-70 years of both sex
3)relapse cases after previous agnikarma of knee joint |
|
| ExclusionCriteria |
| Details |
1. Age below 35 years and above 70 years
2. Patients of Diabetes mellitus, R.A
(Rheumatoid Arthritis) positive, Gross Knee
Joint Effusion
3. Other Diseases like Paralysis, Parkinson’s disease, severe Anemia, and Malignancy.
4. Pregnant and Lactating females
5. Known cases of secondary O.A. due to T.B., Syphilis, AIDS, Leprosy etc.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in sign and symptoms of janu sandhigatvata |
After 1 month of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improves quality of life of person |
After 1 month |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
08/02/2018 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="4" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Kapadiya M, Joshi F, Dudhamal TS. Agnikarma
with Adjuvant Drug in the Management of Frozen Shoulder
(Avabahuka) – A Case Report. Asian Pac. J. Health Sci., 2021;8(4):75-78 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study comprises a clinical study to evaluate the effect of agnikarma and panchatikta guggulu in the management of janu sandhigatvata(osteoarthritis of knee joint). Acharya sushruta has described that the best treatment for vataja and kaphaja is agnikarma. agnikarma can be done when sever pain occurs in twaka, mamsa, sira, snayu, sandhi due to vataprakopa. Agnikarma is non-pharmacological treatmwnt (para-surgical) which has definite role in sandhigatvata. with emphasis of the ayurvedic approach of the agnikarma treatment, which cures the disease and does not require potent analgesics for long period, is selected for trial in this study with the panchatikta guggulu for internal use to prove its better out come.
procedure- in group :A, for 30 days panchatikta guggulu tablet (500mg) 2TDS with luke warm water 1 hour after meal, agnikarma with panchdhatu shalaka 4 sitting of 1 week interval and in group: B,placebo capsule (5oomg) TDS for 30 days , agnikarma with panchdhatu shalaka 4 sitting of 1 week interval will be advised and result will be noticed after 30 days through relief in clinical sign, symptoms and changes in X-Ray knee joint. |