| CTRI Number |
CTRI/2024/07/070983 [Registered on: 22/07/2024] Trial Registered Prospectively |
| Last Modified On: |
12/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
An Ayurvedic study on Apabahuka (Frozen shoulder) |
|
Scientific Title of Study
|
A Comparative clinical study to evaluate the efficacy of Naagara ghrita nasya and Thinthrini taila nasya followed by shulahara kashaya in Apabahuka vis-a-vis frozen shoulder |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kirthana K |
| Designation |
2nd year MD(Ayu)Scholar |
| Affiliation |
Government Ayurveda Medical College and Hospital |
| Address |
Department of Post Graduate Studies in Kayachikitsa Government Ayurveda Medical College and Hospital Visveswaraya Circle Devaraja Mohalla Mysuru
Mysore
KARNATAKA
570001
India |
| Phone |
9591103432 |
| Fax |
|
| Email |
kirthanakumar97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mythrey RC |
| Designation |
Professor and Head of the department |
| Affiliation |
Government Ayurveda Medical College and Hospital |
| Address |
Department of Post Graduate Studies in Kayachikitsa Government Ayurveda Medical College and Hospital Visveswaraya Circle Devaraja Mohalla Mysuru
Mysore
KARNATAKA
570001
India |
| Phone |
8618570803 |
| Fax |
|
| Email |
mythreyrc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kirthana K |
| Designation |
2nd year MD(Ayu)Scholar |
| Affiliation |
Government Ayurveda Medical College and Hospital |
| Address |
Department of Post Graduate Studies in Kayachikitsa Government Ayurveda Medical College and Hospital Visveswaraya Circle Devaraja Mohalla Mysuru
Mysore
KARNATAKA
570001
India |
| Phone |
959103432 |
| Fax |
|
| Email |
kirthanakumar97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda Medical College,Mysuru,karnataka-570001,India |
|
|
Primary Sponsor
|
| Name |
Dr Kirthana K |
| Address |
Department of Post graduate studies in Kayachikitsa ,Government Ayurveda Medical Colege ,Mysore,Karnataka-570001,India |
| Type of Sponsor |
Other [[Self]] |
|
|
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 |
| DrKirthanaK |
Government Ayurveda Medical College and Hospital,Vishweswaraiah circle,Mysore,570001 |
Kayachikitsa OPD,Room number 10 and IP wards of Government Ayurveda Medical College and Hospital,Vishweswaraiah circle,Mysore,570001
Mysore
KARNATAKA |
9591103432
kirthanakumar97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Ayurveda Medical College Mysuru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M750||Adhesive capsulitis of shoulder. Ayurveda Condition: AVABAHUKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Ashtangahridayam, Procedure details: Purvakarma-Mukhabhyanga,
Pradhanakarma-Nasya with Thinthrini taila-8 Bindu (4ml) in each nostril with karnika
Paschat karma-kavala
Shamana aushadi prayoga-Shulaharakashaya with yavakshara,hingu & lavana as prakshepaka dravya will be administered in dosage of 24ml twice a day, after food for consecutive 30 days. )
(1) Medicine Name: Thinthrini taila, Reference: Sahasrayogam, Route: Nasal, Dosage Form: Taila, Dose: 4(ml), Frequency: od, Duration: 8 Days | | 2 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Ashtangahridsayam, Procedure details: Purvakarma-Mukhabhyanga,
Pradhanakarma-Nasya with Naagaraghrita-8 Bindu (4ml) in each nostril with karnika
Paschat karma-kavala
Shamana aushadi prayoga-Shulaharakashaya with yavakshara,hingu & lavana as prakshepaka dravya will be administered in dosage of 24ml twice a day, after food for consecutive 30 days. )
(1) Medicine Name: Naagara ghrita, Reference: Bharathabhaishajaratnakara, Route: Nasal, Dosage Form: Ghrita, Dose: 4(ml), Frequency: od, Duration: 8 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subject fulfilling diagnostic criteria
Subjects fit for nasya
Irrespective of gender,caste and religion |
|
| ExclusionCriteria |
| Details |
Subjects with history of fracture and dislocation of shoulder joint.
Subjects with uncontrolled diabetes mellitus more than 250 mg/dl.
Subjects with blood pressure more than 150/100Hg.
Subjects suffering from any other systemic disorders which interfers with the course of intervention.
Pregnant and Lactating women. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Efficacy of Naagara ghrita nasya followed by shulahara kashaya internally
efficacy of thinthrini taila nasya followed by shulahara kashaya internally in releiving pain , stiffness and improve range of movement measured with help of goniometer scale and subjective parameter |
First assessment - 0th day
Second assessment-9th day
Third assessment – 39th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare efficacy of naagara ghrita nasya & thinthrini taila nasya followed by shulahara kashaya in releiving pain,stiffness,and improve range of movement measured with the help of goniometer |
First assessment - 0th day
Second assessment-9th day
Third assessment – 39thday |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/08/2024 |
| 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="1"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Apabahuka is vedanapradhana nanatmaja vatavyadhi affecting amsapradesha
with predominance of vatakapha dosha.
Cardinal features
of apabahuka are shula ,sthamba,bahupraspandithahara.
These symptoms resembles with the Frozen shoulder.
Frozen shoulder,
also called as Adhesive capsulitis, is characterized by pain and restricted
movement of shoulder, usually in the absence of intrinsic shoulder disease.
This condition develops after prolonged immobility of arm.
Signs and symptoms
typically begin slowly, then get worse over time which hampers the day-to-day
activities like combing, bathing, writing etc making it an issue of concern.
The prevalence
rate of Frozen shoulder globally is
around 2-5%. In Indian population it ranges between 15-25%. Among subjects with
Diabetes mellitus 3-6% encounter frozen shoulder.
Present
contemporary treatment includes oral NSAIDS, Corticosteroids.External therapies
like hot and cold compression packs and Physiotherapy.
According to estimation from World Health Organisation, 80% of the world’s
population relies on traditional medicine for their primary health care.
In classics the
treatment of apabahuka includes Nasya,
Uttarabhaktika Snehapana, Swedana, Nasapana and Shamanoushadi prayoga.
Nasya is the therapeutic procedure in which the
administered intranasal drug strengthens the Urdhvajatru avayava and
eliminate the aggravated doshas.
Ghrita, Taila and Kashaya, selected for the study have vatashleshmaprashamana ,sarvavatarogahara
and shulanivaranam properties.
Considering all the above points,the
study will be undertaken to evaluate efficacy of Naagara ghrita and Thinthrini
taila Nasya followed by Shulahara kashaya as
shamanaprayoga .
|