| CTRI Number |
CTRI/2025/05/086242 [Registered on: 05/05/2025] Trial Registered Prospectively |
| Last Modified On: |
02/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see and compare effect of parinata keriksheeradi oil and teel oil through nasal route in treatment of frozen shoulder |
|
Scientific Title of Study
|
A comparative clinical study of efficacy of marsha nasya of parinata keriksheeradi taila with teel taila in 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 |
Dr Ayman Aslam Kazi |
| Designation |
Post Graduate Resident |
| Affiliation |
APMs Ayurved Mahavidyalaya, Near sion railway staion, sion, mumbai |
| Address |
Department of Panchakarma, Second floor, APMs Ayurved Mahavidyalaya, near sion railway station, sion, mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9821316963 |
| Fax |
|
| Email |
aymankazi777@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajendra Govind More |
| Designation |
HOD |
| Affiliation |
APMs Ayurved Mahavidyalaya, Near sion railway staion, sion, mumbai |
| Address |
Department of Panchakarma, Second floor, APMs Ayurved Mahavidyalaya, near sion railway station, sion, mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9967520554 |
| Fax |
|
| Email |
rmrushi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajendra Govind More |
| Designation |
HOD |
| Affiliation |
APMs Ayurved Mahavidyalaya, Near sion railway staion, sion, mumbai |
| Address |
Department of Panchakarma, Second floor, APMs Ayurved Mahavidyalaya, near sion railway station, sion, mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9967520554 |
| Fax |
|
| Email |
rmrushi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth R.V. Ayurvedic Hospital |
|
|
Primary Sponsor
|
| Name |
Seth RV Ayurvedic Hospital |
| Address |
APMS Ayurved Mahavidyalaya,near sion railway station, sion, mumbai - 400022, Maharashtra, India |
| Type of Sponsor |
Other [Government Aided ] |
|
|
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 Ayman Aslam Kazi |
Seth R.V. Ayurvedic Hospital |
Dept of panchakarma, OPD No. 1, Near sion railway station, sion, mumbai - 400022.
Mumbai
MAHARASHTRA |
9821316963
aymankazi777@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:M00-M99||Diseases of the musculoskeletal system and connective tissue. Ayurveda Condition: AVABAHUKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Parinata keriksheeradi oil, Reference: Sahastra yogam, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Teel oil, Reference: charak chikitsa, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients experiencing symptoms for atleast 3 months
Patients willing to participate and give consent.
Patients who havent recieved any steroid injections or surgery for shoulder pain.
Patients fit for nasya and diagnosed for avabahuka.
Patients pre-diagnosed for adhesive capsulitis.
|
|
| ExclusionCriteria |
| Details |
Patients with shoulder conditions other than adhesive capsulitis, such as rotator cuff tears, osteoarthritis, or rheumatoid arthritis.
Patients with uncontrolled chronic illnesses such as diabetes, cardiovascular diseases, or severe hepatic or renal impairment.
Known allergies or sensitivities to the components of Parinatakeriksheeradi Taila or Teel Taila.
Patients with recent shoulder trauma or surgery within the last 6 months.
Patients with neurological disorders affecting shoulder movement. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ruja, flexion, extension, abduction, adduction |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| sandhi stabhdhata, tenderness, swelling |
7 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)
|
13/05/2025 |
| 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="2" |
|
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 2 to 5 percent of the general
population in India and is common between 30 to 50 years of age. There is
slightly more significant predominance in females (1.4:1) and the non-dominant
hand is often affected. The prevalence of Adhesive Capsulitis was observed to be
17.9 percent in patients with DM as compared to 7 percent in Non-Diabetics in
Indian Population.
Patients with auto-immune disorders, such as thyroid
disorders and diabetes mellitus are more prone to developing adhesive
capsulitis. Additionally, individuals with uncontrolled diabetes mellitus can
experience poor treatment outcome.
The Acharyas have mentioned Nasyakarma as the best line of
treatment for this condition. It is also
a Vatoupakrama (line of treatment of vatavyadhi), so Nasyakarma should
be used in this condition.
Acharya Vagbhata has mentioned mainly three types of
Nasyakarma(13), which are:A) Virechana-it expels the Kaphaadidosha from the
Shirapradesh. B) Bhrihmana/Snehana- it nourishes the parts of Shirabhag. C)
Shaman- it reduces the Vatadi doshas.
Bruhana through Nasya can be done by either ; 1) Marsha
nasya 2) Pratimarsha Nasya. In this condition, Marsha Nasya is indicated for
bruhana effect. |