| CTRI Number |
CTRI/2020/03/024263 [Registered on: 25/03/2020] Trial Registered Prospectively |
| Last Modified On: |
16/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of Dry and moist hot sand bag Ayurveda therapy in relieving Frozen shoulder of diabetes mellitus symptoms |
|
Scientific Title of Study
|
Effectiveness of Valuka Sveda as Tapa and Ushma Methods in Frozen Shoulder Of Diabetes Mellitus - A Pragmatic Comparative Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nusriya M |
| Designation |
Pg Scholar |
| Affiliation |
VPSV Ayurveda College Kottakkal |
| Address |
Department of Panchakarma
VPSV Ayurveda College,Kottakkal
Mudavankulavan (H)
Palankara PO
Malappuram Dist
Kerala
679330
Malappuram
KERALA
676501
India |
| Phone |
8281916724 |
| Fax |
|
| Email |
nusriyamnabeel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nusriya M |
| Designation |
Pg Scholar |
| Affiliation |
VPSV Ayurveda College Kottakkal |
| Address |
Department of Panchakarma
VPSV Ayurveda College,Kottakkal
Mudavankulavan (H)
Palankara PO
Malappuram Dist.
Kerala
679330
Malappuram
KERALA
676501
India |
| Phone |
8281916724 |
| Fax |
|
| Email |
nusriyamnabeel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Subin VR |
| Designation |
Assistant Professor |
| Affiliation |
VPSV Ayurveda College, Kottakkal |
| Address |
Department of Panchakarma
VPSV Ayurveda College, Kottakkal
Para mana, Vairikkulambu road, opposite VPSV Ayurveda College, Kottakkal
Malappuram
KERALA
676501
India |
| Phone |
9961732125 |
| Fax |
|
| Email |
vaidyamadham.dr@gmail.com |
|
|
Source of Monetary or Material Support
|
| VPSV Ayurveda College, Kottakkal, Edarikkode PO, Malappuram Dist, Kerala, 676501 |
|
|
Primary Sponsor
|
| Name |
VPSV Ayurveda College Kottakkal |
| Address |
VPSV Ayurveda College Kottakkal Edarikkode Malappuram Kerala
Pin 676501 |
| Type of Sponsor |
Other [Aided Ayurveda 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 |
| Nusriya M |
VPSV Ayurveda college hospital, Kottakkal Edarikkode po Malappuram Kerala pin- 676501, |
Department of Panchakarma, Room no.110
Malappuram
KERALA |
8281916724
nusriyamnabeel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,Vaidyaratnam PS Varier Ayurveda College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M750||Adhesive capsulitis of shoulder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tapa method |
External heat application with 2 cloth bags, each prepared with 200 gm of VÄluka, which is roasted with dhÄnyamla over the affected shoulder for 30 minutes duration for a period of maximum 14 days or subsidence of symptoms which ever is earlier
|
| Comparator Agent |
Ushma method |
External heat application with 2 cloth bags, each prepared with 200 gm of VÄluka,and dipped in hot dhÄnyamla over the affected shoulder for 30 minutes duration for a period of maximum 14 days or subsidence of symptoms which ever is earlier
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Having clinical features of stage 2 and 3 of Frozen Shoulder
Fit for Svedana karma
Participants Who have given informed consent |
|
| ExclusionCriteria |
| Details |
1.History of trauma to shoulder
2.History of surgery on the particular shoulder
3.clinical findings of Rotator cuff lesion
4.Any neurological condition affecting shoulder
5.FBS value more than 200
6.Any other known cases of systemic illness
7.Pregnant and Lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.SPADI
2.Goniometry
3.Event Evaluation Scale for svedakarmukata |
1.Immediately after completion of treatment
2.15 days after completion of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.SPADI
2.Goniometry
3.Event Evaluation Scale for Svadakarmukatha |
15 days after completion of treatment |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/03/2020 |
| 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="0"
Months="10"
Days="7" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Will be submitted as Dissertation to Kerala University of Health Science Thrissur |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Frozen shoulder or Adhesive Capsulitis is a clinical syndrome characterised by painful restriction of both active and passive movements of shoulder. It is considered as one of the most common cause of shoulder in which females are more affectedI. it is having an incidence of 2% in general population and 10-30% in Diabetes mellitus patients. Valuka is an important, easy and effective material for ruksha sveda, and is mentioned under both tapa and ushma sveda in classics.In this study, Valuka sveda as Tapa is being compared with Ushma Valuka sveda (by dipping the pottali in heated Dhanyamla) for assessment of effectiveness in Frozen shoulder of Diabetes mellitus. Cases will be diagnosed with specialised structured case proforma. Patents are then randomly allocated into two groups where one group receives Tapa valuka sveda and another group receives Ushma valuka sveda up to Vyadhi samana or maximum 14 days. Daily monitoring will be done. For vyadhi samana, SPADI will be assessed before commencement of course of treatment, on each day after treatment, after completion of course, and after follow up. and Goniometry will be assessed before course of treatment, after course and after follow up. Sveda karmukatha will be assessed using an Event Evaluation Scale prepared by compiling all Samyak yoga, Ayoa and Atiyoga features of svedana and recording them on each day of intervention. Data will be collected and statistically analyse for the conclusion. |