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Clinical Trial Details (PDF Generation Date :- Mon, 27 Sep 2021 17:09:54 GMT)
CTRI Number CTRI/2017/09/009894 [Registered on: 22/09/2017] - Trial Registered Retrospectively Last Modified On 19/09/2017 Post Graduate Thesis Yes Type of Trial Interventional Type of Study Drug Medical Device Ayurveda Study Design Randomized, Parallel Group, Active Controlled Trial Public Title of Study Heat therapy(agnikarma) in Tennis Elbow Scientific Title of An Open Label Comparative Clinical Study to assess the Efficacy of Agnikarma in Snayugatavata Study Treatment Protocol with Agnikarma Alone in Tennis Elbow Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr Lakshmy C Senan Trial Coordinator (multi-center study) Designation PG Scholar-Ayurveda medicine Affiliation AMRITA SCHOOL OF AYURVEDA Address Department of Shalya Tantra Amrita School of Ayurveda Vallikavu Kollam Amrita School of Ayurveda,Amrita Viswavidyapeetham Vallikavu, Clappana PO, Kollam, Kerala, India, PIN- 690525 Kollam KERALA 690525 India Phone 9567554883 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Rabinarayan Tripathy Query) Designation Head of the Department, Department of Shalya Tantra Affiliation AMRITA SCHOOL OF AYURVEDA Address Amrita School of Ayurveda,Amrita Viswavidyapeetham Vallikavu, Clappana PO, Kollam, Kerala, India, PIN- 690525 Kollam KERALA 691002 India Phone 9567554883 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Lakshmy C Senan Designation PG Scholar-Ayurveda medicine Affiliation AMRITA SCHOOL OF AYURVEDA Address Amrita School of Ayurveda,Amrita Viswavidyapeetham Vallikavu, Clappana PO, Kollam, Kerala, India, PIN- 690525 Kollam KERALA 691002
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India Phone 9567554883 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Amrita School OF Ayurveda, Amrita Vishwa Vidyapeetam, Vallikavu, Primary Sponsor Primary Sponsor Details Name AMRITA SCHOOL OF AYURVEDA Address Amrita School of Ayurveda, Amrita Viswavidyapeetham, Vallikavu, Clappana PO, Kollam, Kerala, India, PIN- 690525 Type of Sponsor Private medical college Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment Afghanistan Albania Algeria Andorra Angola Antigua and Barbuda Argentina Armenia Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bhutan Bolivia Bosnia and Herzegovina Botswana Brazil Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Central African Republic
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Chad Chile China Colombia Comoros Congo Cook Islands Costa Rica Cote d'Ivoire Croatia Cuba Cyprus Czech Republic Democratic People's Republic of Korea Democratic Republic of the Congo Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Fiji Finland France Gabon Gambia Georgia Germany Ghana Greece Grenada Guatemala Guinea Guinea-Bissau Guyana Haiti Honduras Hong Kong Hungary Iceland India Indonesia Iran (Islamic Republic of)
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Iraq Ireland Israel Italy Jamaica Japan Jordan Kazakhstan Kenya Kiribati Kuwait Kyrgyzstan Lao People's Democratic Republic Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Lithuania Luxembourg Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Mauritania Mauritius Mexico Micronesia (Federated States of) Monaco Mongolia Montenegro Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Zealand Nicaragua Niger Nigeria Niue Norway Oman
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Other Pakistan Palau Panama Papua New Guinea Paraguay Peru Philippines Poland Portugal Qatar Republic of Korea Republic of Moldova Romania Russian Federation Rwanda Saint Kitts and Nevis Saint Lucia Saint Vincent and the Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands Somalia South Africa Spain Sri Lanka Sudan Suriname Swaziland Sweden Switzerland Syrian Arab Republic Taiwan Tajikistan Thailand The former Yugoslav Republic of Macedonia Timor-Leste Togo Tonga
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Trinidad and Tobago Tunisia Turkey Turkmenistan Tuvalu Uganda Ukraine United Arab Emirates United Kingdom United Republic of Tanzania United States of America Uruguay Uzbekistan Vanuatu Venezuela (Bolivarian Republic of) Viet Nam Yemen Zambia Zimbabwe Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Lakshmy C Senan Amrita School of Amrita School of 9567554883 Ayurveda Ayurveda, Amrita Viswavidyapeetham, drlakshmybalaji@yahoo Vallikavu, Clappana .com PO, Kollam, Kerala, India, PIN- 690525 Kollam KERALA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Amrita Institute of Approved 20/06/2016 No Medical Science-Institutional Ethics Committee Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients tennis elbow patients Intervention / Type Name Details Comparator Agent Intervention thermal cauterization 1.AGNIKARMA(thermal cauterization/ application of heat energy over the specific site) Comparator Agent upanaha,pichu,agnikarma 1. upanaha-12 hourly bandage with hot medicated paste of kottamchukkadichoorna, kottamchukkadi taila, saindhava and dhanyamla 2.pichu- oil applied over cotton in a localized area 3. agnikarma-(thermal
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cauterization/ application of heat energy over the specific site) Inclusion Criteria Inclusion Criteria Age From 20.00 Year(s) Age To 60.00 Year(s) Gender Both Details 1.Patients selected irrespective of sex, religion, Occupation, socioeconomic status etc
2.Diagnosis on the basis of signs and symptoms found in Tennis elbow like
3.Pain on the outer side of the elbow jt.
4.Radiation of pain from elbow to forearm or hand.
5.Tenderness over the lateral epicondyle
6.Weak grip so that there is Inability to do daily routine work
7.Pricking sensation
8.Cozen’s test positive[13]
9.Mill’s maneuver positive[14]
10.Patient who are willing to undergo trial, are only registered.
Exclusion Criteria Exclusion Criteria Details 1.Patients not willing to undergo trial. 2.Patients below 20 years and above 60 years of age. 3.Pregnant women. 4.Patients having joint disorders (viz. RA, OA, GA of elbow joint), Tuberculosis, Diabetes or having associated some other constitutional disorders etc 5.Malignant tumors, senile osteoporosis etc in and around the elbow region. 6.Patients associated with Golfer’s elbow, Olecranon bursitis, Radial tunnel syndrome etc. 7.Patients with history of compound fracture, Pathological fracture, non united fracture and mal-united fracture of complaining limb 8.Agnikarma anarhas
Method of Generating Coin toss, Lottery, toss of dice, shuffling cards etc Random Sequence Method of Case Record Numbers Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints 1.Pain on the outer side of the elbow joint Periodic observation will be done on 0th day, 8th assessed by Visual Analogue Scale. day, 15 th, 30 th, and 90 th day. 2. Radiation of pain towards forearm or hand. 3. Restricted range of movements. 4. Pricking sensation
OBJECTIVE CRITERIA: 1. Tenderness over the lateral epicondyle 2. Cozen’s test positive 3. Mill’s maneuver positive
Secondary Outcome Outcome Timepoints recurrence within 90 days Target Sample Size Total Sample Size=60 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 4 Date of First 11/11/2016
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Enrollment (India) Date of First 11/11/2016 Enrollment (Global) Estimated Duration of Years=1 Trial Months=6 Days=1 Recruitment Status of Open to Recruitment Trial (Global) Recruitment Status of Open to Recruitment Trial (India) Publication Details none yet Brief Summary The study is expected to be done as an open label comparative clinical study in which 60 patients excluding the dropouts are randomly selected for the study, after the diagnosis. The treatment is imparted to them for 8 days in two groups GROUP A and GROUP B on OP basis. Periodic observation will be done on 0th day, 8th day, 15 th, 30 th, and 90 th day.The patients will not have to bear any financial burden for this
a) GROUP A
A total of 30 Patients are selected for 8 days treatment.
For the first seven days upanaha is done in the morning with kottamchukkadi choornam, dhanyamlam, kottamchukkadi taila & saindhava and wrapped with arka patra and left for 12 hours. It is followed by local pichu with warm kottamchukkadi taila for 30 minutes.
On the 8th day Agnikarma is done with panchadhatu salaka as bindhu type dagdha, around the most tender point at 1 inch circumferential area, followed by kumari /Aloe vera gel application at the site of burning.
b) GROUP B
30 patients are selected randomly and agnikarma alone is done in two sittings with 7 days gap between them i.e. on the 1st day and the 8th day.
All the patients will be advised to take pichila anna (unctous diet)in the previous night
Sharaath (autumn) Greeshma (summer) rtu/seasons will be exempted from the procedure .
th th th th th Periodic observation will be done on 0 day, 8 day, 15 , 30 , and 90 day.
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