| CTRI Number |
CTRI/2022/07/044372 [Registered on: 27/07/2022] Trial Registered Prospectively |
| Last Modified On: |
25/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of Avabahuka (Frozen Shoulder) by Manjishtadi Taila and Mahmash Taila Nasya. |
|
Scientific Title of Study
|
Camparative Evaluation of Manjishtadi Taila and Mahamasha Taila Nasya in the Management of Avabahuka (Frozen Shoulder). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kanchan R Sorte |
| Designation |
PG Scholer |
| Affiliation |
Datta Meghe Institute of Medical Sciences (Deemed University) |
| Address |
Department of Panchakarma Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod (H) Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8806098392 |
| Fax |
|
| Email |
kanchansorte30@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinod Ade |
| Designation |
Proffeser |
| Affiliation |
Datta Meghe Institute of Medical Sciences (Deemed University) |
| Address |
Datta Meghe Institute of Medical Sciences (Deemed University)
Department of Panchakarma Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod (H) Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9689365368 |
| Fax |
|
| Email |
dr.vinodade@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kanchan R Sorte |
| Designation |
PG Scholer |
| Affiliation |
Datta Meghe Institute of Medical Sciences (Deemed University) |
| Address |
Department of Panchakarma Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod (H) Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8806098392 |
| Fax |
|
| Email |
kanchansorte30@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Panchakarma, Mahatma Gandhi Ayurveda College Hospital and Research Centre, Salod (H), Wardha |
|
|
Primary Sponsor
|
| Name |
Dr Kanchan R Sorte |
| Address |
Department of Panchakarma Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod (H) Wardha |
| 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 |
| Kanchan R Sorte |
Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod (H) Wardha |
Department of Panchakarma OPD no. 40 Wardha MAHARASHTRA
Wardha
MAHARASHTRA |
08806098392
kanchansorte30@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Medical Sciences(Deemed University) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M625||Muscle wasting and atrophy, not elsewhere classified. Ayurveda Condition: AVABAHUKAH, (2) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Manjisthadi Taila, Reference: Vangasena Samhita chapter 60 Shloka 120, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 8(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Mahamash Taila, Reference: Chakradatta Samhita Vatavyadhi Chikitsa shloka 187 , Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 8(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Avabahuka is diagnosed according to the classical sign and symptoms include restricted movement and pain in the affected shoulder, stiffness and muscle wasting
2) Patients of either sex between the age group of 18-60 years
3) Patients fit for Nasya Karma.
4) Patients are ready to give consent and abide by the study protocol. |
|
| ExclusionCriteria |
| Details |
1) Patients complaining of fracture and dislocation.
2) patients with a history of Hemorrhagic Hemiplegia.
3) Patients having nasal disorders.
4) Patients having diabetes. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| We will see the imapct of nasya in Avabahuka on subjective parameters during treatment.It is hypothesized that Mahamasha taila nasya and Manjishthadi taila nasya will be more effective with no adverse effect. |
six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| We will see the effect of Mahamasha taila nasya and Manjishthadi taila nasya on objective parameters by assessing range of motion.The secondary outcome is to compare the efficacy of Manjishthadi taila with mahamasha taila nasya in Avabahuka(Frozen shoulder) |
Six months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 Enrollment (India)
|
01/08/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients will be recruited from inclusion criteria and study the efficacy of Manjisthadi taila and Mahamash taila nasya in Avabahuka To study the efficacy of Manjisthadi taila Nasya in Avabahuka. To study the efficacy of Mahamash taila Nasya in Avabahuka Comparative evaluation of the efficacy of Manjisthadi taila and mahamash taila nasya in avabahuka. |