| CTRI Number |
CTRI/2020/03/024179 [Registered on: 23/03/2020] Trial Registered Prospectively |
| Last Modified On: |
13/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Nasal Medication and Patra Pottali Pinda Sweda in Avabahuka (Frozen shoulder) |
|
Scientific Title of Study
|
A clinical study of application of Mahamasha taila nasya and patra pottali pinda sweda in the management of avabahuka w.s.r. to frozen shoulder |
| Trial Acronym |
NASWED |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manoranjan Muduli |
| Designation |
M.D. Scholar, Panchakarma Department |
| Affiliation |
Government P.G. Ayurveda College and Hospital, Varanasi |
| Address |
Government P.G. Ayurveda College and Hospital, Chaukaghat, Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
8018334667 |
| Fax |
|
| Email |
manoranjanmuduli2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manoranjan Muduli |
| Designation |
M.D. Scholar, Panchakarma Department |
| Affiliation |
Government P.G. Ayurveda College and Hospital, Varanasi |
| Address |
Government P.G. Ayurveda College and Hospital, Chaukaghat, Varanasi
UTTAR PRADESH
221002
India |
| Phone |
8018334667 |
| Fax |
|
| Email |
manoranjanmuduli2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manoranjan Muduli |
| Designation |
M.D. Scholar, Panchakarma Department |
| Affiliation |
Government P.G. Ayurveda College and Hospital, Varanasi |
| Address |
Government P.G. Ayurveda College and Hospital, Chaukaghat, Varanasi
UTTAR PRADESH
221002
India |
| Phone |
8018334667 |
| Fax |
|
| Email |
manoranjanmuduli2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government P.G. Ayurveda College and Hospital, Varanasi |
|
|
Primary Sponsor
|
| Name |
Government PG Ayurveda College and HospitalVaranasi |
| Address |
Government P.G. Ayurveda College and Hospital,Varanasi |
| 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 |
| Dr P L Sankhua |
Government P.G. Ayurveda College and Hospital |
Room number 8 , Department of Panchakarma,Government P.G. Ayurveda College and Hospital, Varanasi
Varanasi
UTTAR PRADESH |
7376468851
pls_bls@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ,Government P.G. Ayurveda College and Hospital Varanasi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Niramish Mahamasha taila Nasya
Patra pottali pinda sweda |
Pinda sweda is applied for 30 minutes followed by 8 drops of taila nasya into each nostrils |
| Intervention |
Niramish Mahamasha Taila Nasya |
8 drops in both nostrils in empty stomach in morning |
| Intervention |
Patra Pottali Pinda Sweda |
once a day for 30 minutes |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Bahupraspanditahar(Restricted movement of shoulder)
Amsabandhana Shosha(Waisting of muscle).
Sira Akunchana / Sthamba(Stiffness).
Bahu Shoola(Pain in Shoulder joint).
Adhesive Capsulitis or Frozen shoulder
|
|
| ExclusionCriteria |
| Details |
Auto immune disorders like SLE, RA etc.
Post Traumatic injuries, fractures.
Dislocation of Shoulder joint.
Underlying illness such as Thyroid diseases and hyper lipidemia
Cervical spondylosis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain, stiffness, restricted movement, waisting of muscles of shoulder joint |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No recurrence of signs and symptoms |
7 days |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 |
|
Date of First Enrollment (India)
|
02/05/2020 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Yet not be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Clinical study Setting: Patient suffering from Avabahuka will be selected from OPD and IPD of Government P.G. Ayurveda College and Hospital, Chaukaghat, Varanasi, 221002 1) Inclusion Criteria: Patents between age group 20-70 years, both gender , having clinical features of Avabahuka 2) Exclusive Criteria:Auto immune disorders like SLE, RA, Post traumatic injuries, fractures, Dislocation of shoulder joint, Thyroid disease , Cervical spondylosis 3) Grouping: 90 patients will be randomly assigned in 3 groups. Group 1: 8 drops of Niramish Mahamasha taila nasya will be given to each nostrils, duration 15 days Group 2: Patra pottali pinda sweda is applied over affected area for 30 minutes ,duration15 days Group 3: Patra pottali pinda sweda is applied for 30 minutes folled by 8 drops of Niramish Mahamasha taila nasya to each nostrils for duration 15 days Follow up will be done for 7 days after completion of treatment 4) Statistical method of analysis: The parameters of baseline data will be compared with the follow up status for assessment of results All the result analysis will be done by using SPSS ver. 20 softer, and obtained result will be interpreted statistically for "p" value , repeated measures Anova test |