| CTRI Number |
CTRI/2025/02/080532 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [curative] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EFFECT OF DASHAMULABALAMASHA TAILA AND MASHADI TAILA NASYA IN APABAHUKA |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF DASHAMULABALAMASHA TAILA NASYA AND MASHADI TAILA NASYA IN APABAHUKA WITH SPECIAL REFERENCE TO 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 Bhavana |
| Designation |
PG Scholar |
| Affiliation |
Bhagawan Mahaveer Jain Ayurvedic Medical College, Hospital and PG Centre, Gajendragad |
| Address |
Department of PG studies in Panchakarma, Bhagawan Mahaveer Jain Ayurvedic Medical College, Hospital and PG Centre, Gajendragad 582114
Gadag
KARNATAKA
582114
India |
| Phone |
9066137441 |
| Fax |
|
| Email |
bhavanalaxmanshetty129@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijaykumar B Math |
| Designation |
Associate Professor |
| Affiliation |
Bhagawan Mahaveer Jain Ayurvedic Medical College, Hospital and PG Centre, Gajendragad |
| Address |
Department of PG studies in Panchakarma, Bhagawan Mahaveer Jain Ayurvedic Medical College, Hospital and PG Centre, Gajendragad 582114
Gadag
KARNATAKA
582114
India |
| Phone |
9448003269 |
| Fax |
|
| Email |
drvijaykumarmath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhavana |
| Designation |
PG Scholar |
| Affiliation |
Bhagawan Mahaveer Jain Ayurvedic Medical College, Hospital and PG Centre, Gajendragad |
| Address |
Department of PG studies in Panchakarma, Bhagawan Mahaveer Jain Ayurvedic Medical College, Hospital and PG Centre, Gajendragad 582114
Gadag
KARNATAKA
582114
India |
| Phone |
9066137441 |
| Fax |
|
| Email |
bhavanalaxmanshetty129@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bhagawan Mahaveer Jain Ayurvedic Medical College, Hospital and PG Centre, Gajendragad 582114 |
|
|
Primary Sponsor
|
| Name |
Dr Bhavana |
| Address |
Panchakarma PG classroom, Bhagawan Mahaveer Jain Ayurvedic Medical College, Hospital and PG Centre, Gajendragad 582114 |
| Type of Sponsor |
Private 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 |
| Dr Bhavana |
Bhagawan Mahaveer Jain Ayurvedic Medical College, Hospital and PG Centre, Gajendragad 582114 |
Bhagawan Mahaveer Jain Ayurvedic Medical College, Hospital and PG Centre, Gajendragad 582114
Gadag
KARNATAKA |
9066137441
bhavanalaxmanshetty129@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bhagawan Mahaveer Jain Ayurvedic Medical College, Hospital and PG Centre, Gajendragad 582114 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M708||Other soft tissue disorders related to use, overuse and pressure. Ayurveda Condition: AVABAHUKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Yogaratnakara, Procedure details: Nasya karma (Marsha nasya)
dose 8 drops will be done with Mashaadi Taila..
)
(1) Medicine Name: Mashadi taila, Reference: Yogaratnakara, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Yogaratnakara, Procedure details: Nasya karma (Marsha nasya) dose 8 drops will be done with Dashamulabalamasha Taila..)
(1) Medicine Name: Dashamulabalamasha taila, Reference: Yogaratnakara, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having signs and symptoms of Apabahuka will be selected.
Patients of either sex between age group of 18-60 years will be selected.
Patients who are fit for Nasya karma will be selected. |
|
| ExclusionCriteria |
| Details |
1.Patients with other systemic disorders that interfere with the course of treatment are excluded from the study.
2.Individuals having dislocations or fractures of shoulder joint will be excluded.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the symptoms such as Bahushoola, Bahustambha, Bahupraspanditahani |
14th and 21st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improve in the range of movement of shoulder, Improve in the quality of life. |
14th, 21st |
|
|
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)
|
05/03/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
THIS STUDY IS PUT FORWARD TO EVALUATE THE EFFICACY OF DASHAMULABALAMASHA TAILA NASYA
AND MASHAADI TAILA NASYA IN APABAHUKA W.S.R TO FROZEN SHOULDER.
HYPOTHESIS
1.
H0: There is no significant effect of Dashamulabalamasha Taila Nasya and Mashaadi Taila Nasya in the management of Apabahuka.
2.
H1: There is significant effect of
Dashamulabalamasha
Taila Nasya than Mashaadi Taila Nasya in the management of Apabahuka.
3.
H2: There is significant effect
of Mashaadi Taila Nasya than
Dashamulabalamasha
Taila Nasya in the management of Apabahuka.
4.
H3: There is equal effect of Dashamulabalamasha
Taila
Nasya and Mashaadi Taila Nasya in the management of Apabahuka. |