| CTRI Number |
CTRI/2018/01/011166 [Registered on: 05/01/2018] Trial Registered Prospectively |
| Last Modified On: |
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| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Other (Specify) [Leech Application and Agni Karma] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic Management of Joint Pains |
|
Scientific Title of Study
|
A CLINICAL STUDY ON AGNIKARMA AND JALAUKA AVACHARANA WITH ABHA GUGGULU IN MANAGEMENT OF SANDHIGATA VATA (OSTEOARTHRITIS OF KNEE JOINT) |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vyasadeva Mahanta |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
OPD No 104, First Floor, Hospital Block, Dept of Shalya Tantra, All India Institute of Ayurveda, Gautampuri, Sarita Vihar
South DELHI 110076 India |
| Phone |
|
| Fax |
|
| Email |
drvyasayu@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sanjay Kumar Gupta |
| Designation |
Professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
OPD No 104, First Floor, Hospital Block, Dept of Shalya Tantra, All India Institute of Ayurveda, Gautampuri, Sarita Vihar
South DELHI 110076 India |
| Phone |
|
| Fax |
|
| Email |
drskgupta17@gmail.com |
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Details of Contact Person Public Query
|
| Name |
Dr Saroj Meena |
| Designation |
PG Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
OPD No 104, First Floor, Hospital Block, Dept of Shalya Tantra, All India Institute of Ayurveda, Gautampuri, Sarita Vihar
South DELHI 110076 India |
| Phone |
|
| Fax |
|
| Email |
sarojmeenajpr007@gmail.com |
|
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Source of Monetary or Material Support
|
| All India Institute of Ayurveda, Gautampuri, Sarita Vihar |
|
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Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
Gautampuri, Sarita Vihar, New Delhi - 110076 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vyasadeva Mahanta |
All India Institute of Ayurveda |
OPD No 104, First Floor, Hospital Block, Dept of Shalya Tantra, All India Institute of Ayurveda, Gautampuri, Sarita Vihar South DELHI |
8368104072
drvyasayu@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
joint pain, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Abha Guggulu and Agnikarma |
1 gm of Abha Guggulu thrice a day with like warm water after food will be administered for 30 days. Besides, agnikarma with Pancha dhatu Shalaka will be done once in a week, maximum four sittings will be done. |
| Comparator Agent |
Abha Guggulu and Jalaukavacharana |
1 gm of Abha Guggulu thrice a day with like warm water after food will be administered for 30 days. Besides this; Jalauka avacharana with 04 Jalaukas in 1 sitting will be done once in a week, maximum four sittings will be done. |
|
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Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from Sandhigata Vata (Osteoarthritis of knee joint). |
|
| ExclusionCriteria |
| Details |
Patients with Knee joint effusion, Known cases of secondary OA due to TB, Syphilis etc.; suffering with Diabetes mellitus, Severe anaemia, malignancy, bleeding disorders etc. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the comparative clinical efficacy of Agnikarma and Jalauka Avacharana of
Management of Sandhigata Vata |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in quality of life |
2 Months |
|
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Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 2/ Phase 3 |
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Date of First Enrollment (India)
|
02/04/2018 |
| 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) |
Not Yet Recruiting |
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Publication Details
|
The outcome will be disseminated among peer reviewed journals. |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Osteoarthritis (OA) is predominantly a disease of the elderly but no age is exempted. It is caused by wear and tear of the joint. In OA, the top layer of cartilage breaks down and wears always. Worldwide OA is the most common joint disorder. OA is the commonest from of joints disease which is a painful and disabling in advancing years of life. Before 60 years of age 10 out of 100 and after 60 years 75 out of 100 persons suffers from OA of knee joints. After 60 years of age, this disease creates so much trouble that medical consultation becomes mandatory. Worldwide OA is the most common articular disease of people of 65 years and above. In Ayurveda OA can be correlated with Sandhigata Vata. It is characterised by the symptoms of Shotha (swelling), Shula (pain), Vata Purna Driti Sparsha (palpable as an air filled bag) and Akunchana Prasarane Vedana (pain on flexion and extension of the joint), Hantisandhi (structural changes) and Atopa (crepitus). In modern medicine various treatment options are available like conservative treatment, epidural steroid injection, radicular infiltration, surgical methods but all modalities have their own limitations and certain complications. In Ayurveda, Snehana, Upanaha, Agnikarma, Raktamokshana, Panchakarma, Bheshaja Chikitsa etc. have been recommended in the management of such manifestations. Among these Agnikarma and Raktamokshana have their own therapeutic values in the management of Sandhigata Vata. Jalauka avacharana is a kind of Raktamokshana, which has gained greater attention globally because of its medical values. It is also a procedure adviced in the management of OA. Abha Guggulu is known for its Shothahara (anti-inflammatory), Shulahara (analgesic), Rasyana (Rejuvenative), Sandhankara (healing properties) actions. It is anticipated to be helpful in the treatment of OA. Though, it is being used in Ayurveda; but no comparative efficacy is available; considering which the current study is planned. |