| CTRI Number |
CTRI/2025/01/079373 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To see and compare the effect of Dashamuladi Yamak sneha and Teela taila administered through nasal route in Avabahuka w.s.r.to Adhesive capsulitis |
|
Scientific Title of Study
|
A clinical comparative evaluation of Dashamuladi yamaka sneha and teel taila marsha nasya in the management of Avabahuka w.s.r to adhesive capsulitis of shoulder joint |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aishwarya Anil Pawar |
| Designation |
Post graduate resident |
| Affiliation |
APMs Ayurved mahavidyalaya Sion Mumbai |
| Address |
Department of Panchakarma, Second floor, APMs Ayurveda
Mahavidyalaya, Near sion railway station, sion east, mumbai
Mumbai
MAHARASHTRA
400022
India
Mumbai
MAHARASHTRA
400022
India |
| Phone |
8999765726 |
| Fax |
|
| Email |
dr.aishwaryaapawar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Tathed |
| Designation |
Assistent professor |
| Affiliation |
APMs Ayurved mahavidyalaya Sion Mumbai |
| Address |
Dept of panchakarma 2nd floor APMs Ayurved mahavidyalaya Sion near sion railway station MUmbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9867715592 |
| Fax |
|
| Email |
drpankajtathed@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pankaj Tathed |
| Designation |
Assistent professor |
| Affiliation |
APMs Ayurved mahavidyalaya Sion Mumbai |
| Address |
Dept of panchakarma 2nd floor APMs Ayurved mahavidyalaya Sion near sion railway station MUmbai
MAHARASHTRA
400022
India |
| Phone |
9867715592 |
| Fax |
|
| Email |
drpankajtathed@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Panchakarma, Second floor, APMs Ayurveda
Mahavidyalaya, Near sion railway station, sion east, mumbai
Mumbai
MAHARASHTRA
400022
India |
|
|
Primary Sponsor
|
| Name |
Aishwarya Anil Pawar |
| Address |
Department of Panchakarma, Second floor, APMs Ayurveda
Mahavidyalaya, Near sion railway station, sion east, mumbai
Mumbai
MAHARASHTRA
400022
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 |
| Aishwarya Anil Pawar |
Seth RV Ayurvedic Hospital sion |
Dept of panchakarma opd no 1 APMs Ayurved Mahavidyalaya Sion near sion railway station
sion east Mumbai 400022 maharashtra
Mumbai
MAHARASHTRA |
8999765726
dr.aishwaryaapawar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| APMs Ayurved Mahavidyalaya Sion IEC |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dashamuladi Yamak sneha, Reference: yogratnakar vatvyadhi 144, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Teel Taila, Reference: -, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
patient of both genders.
age group - above 18 years and below 70 years
radiological evidences of adhesive capsulitis
pain and restricted movement of shoulder joint.
patient diagnosed with Avabahuka and decreased RoM
patient diagnosed with adhesive capsulitis.
patients having controlled DM. |
|
| ExclusionCriteria |
| Details |
fracture of shoulder joint.
post surgical shoulder pain.
congenital bone and joint deformity
known patient CA and TB spine.
HIV and Hepatitis
lactating mother
pregnant women |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
flexion
abduction
hyperextension |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Ruja (pain) during flexion and extension
sandhikriya kashtata |
15 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/02/2025 |
| 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="6"
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
|
Adhesive Capsulitis affects around 7 % of the general population and is common
between 30 to 50 years of age old.Adhesive Capsulities was seen in 17.9% in DM
compared to 7% in Non Diabetics in Indian Population. They have mentioned that
Nasyakarma is the best line of treatment for this condition. It is also a line of therapy
treatment Vatoupakrama, so Nasyakarma should be used in this condition. Acharya
Vagbhatta has mentioned mainly three types of Nasyakarma are
A) Virechana- it expelles the Kaphaadidosha from the Shirapradesh.
B) Bhrihmana/Snehana- it nourishes the parts of Shirabhag.
C) Shaman- it reduces the Vatadidoshas.
D) Bhrihmana Nasya is again divided into two types: Marsh and Pratimarsha
Nasya. In this condition, Marsha Nasya is indicated. As Acharya Yogratnakara have
mentioned
Dashamuladi Yamaka Sneha Nasya can be used in the Management of Adhesive
Capsulitis SCOPE OF STUDY
There are several Ayurvedic Preparations for treating Avabahuka that can be used
both internally and externally
It is necessary to study and evaluate efficacy of medications by scientific research Dashamuladi yamaka Sneha contents are Bilva ,Agnimantha ,Gambhari ,Shyonak Patala , Brihati, Kantakari , Shaliparni, Gokshura , Prishnaparni, Bala,
Masha all these dravyas will follow the sutra to nasya karma and it is useful for
Avabahuka1 |