| CTRI Number |
CTRI/2025/03/083293 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of parinitakeriksheeradi oil nasel drops with vatari guggulu tablet over masha oil nasal drops with rasnadi guggulu tablet in the management of shoulder pain |
|
Scientific Title of Study
|
A Randomized comparitive clinical study to evaluate the efficacy of parinitakeriksheeradi taila nasya with vatari guggulu over masha taila nasya with rasnadi guggule in the management of avabahuka |
| 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 Rohini L Hirgude |
| Designation |
PG scholar |
| Affiliation |
BLDEAS AVS AMV, VIJYAPUR |
| Address |
Department of kayachikitsa BLDE assosiations AVS AMV,Hospital and Research centre, Bagalkot road,vidyanagar, Murankeri,vijayapur
Bijapur
KARNATAKA
586109
India |
| Phone |
9145054311 |
| Fax |
|
| Email |
rohinihirgude083@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay M Kadlimatti |
| Designation |
Principal and Professor |
| Affiliation |
BLDEAS AVS AMV Hospital and Research centre |
| Address |
Department of kayachikitsa,BLDE associations AVS ayurveda mahavidyalaya hospital and research centre,Bagalkot road, Vidya Nagar,Murankeri,vijayapura
Bijapur
KARNATAKA
586109
India |
| Phone |
8970744656 |
| Fax |
|
| Email |
ayursanjay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay M Kadlimatti |
| Designation |
Principal and Professor |
| Affiliation |
BLDEAS AVS AMV Hospital and Research centre |
| Address |
Department of kayachikitsa,BLDE associations AVS ayurveda mahavidyalaya hospital and research centre ,Bagalkot road,vidyanagar ,murankeri,vijayapura
Bijapur
KARNATAKA
586109
India |
| Phone |
8970744656 |
| Fax |
|
| Email |
ayursanjay@gmail.com |
|
|
Source of Monetary or Material Support
|
| BLDE Association AVS Ayurveda Mahavidyalaya hospital and research centre,bagalkot road,vidya nagar,murankeri,vijayapura,karnataka |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 Rohini L Hirgude |
Dr Rohini L Hirgude |
department of kaychikitsa BLDE Associations AVS Ayurveda Mahavidyalaya Hospital and Research centre,bagalkot road,vidyanagar,Murankeri,Vijayapura
Bijapur
KARNATAKA |
9145054311
rohinihirgude083@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committe BLDEA AVS Ayurveda Mahavidyalaya Hospital and research centre |
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 | Procedure | - | nasyam (viShopakramaH), नस्यम् (विषोपक्रमः) | (Procedure Reference: Ashtanga Hridaya sutrasthana chapter 20/1, Procedure details: At uttamanga pradesha snehana and swedana after that ask patient to sleep in supine position with sniffing position of neck. Then put 8 drops of oil in each nostrils after that gandush is adviced)
(1) Medicine Name: Parinitakereksheeradi Taila , Reference: Sahasrayoga Chapter 4 sneha Kalpana , Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 8(drops), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | nasyam (viShopakramaH), नस्यम् (विषोपक्रमः) | (Procedure Reference: Ashtanga Hridaya Sutrasthana Chapter 20/1, Procedure details: At uttamanga pradesha snehana and swedana after that ask patient to sleep in supine position with sniffing position of neck. )
(1) Medicine Name: Masha Taila , Reference: Bhaishajya Ratnavali Chapter 26/555, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 8(drops), Frequency: od, Duration: 7 Days | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vattari Guggulu , Reference: Bhaishajya Ratnavali Chapter 29/152-154, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -koushana jala), Additional Information: - | | 4 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Rasnadi Guggulu , Reference: Brihan Nighantu Ratnakar Chapter Vatavyadhikarmavipaka page No. 485, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: - koushana Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects presenting with the classical signs and symptoms of avabahuka.
Subjects of either gender aged between 20-60years.
Subjects willing and able to participate in the study |
|
| ExclusionCriteria |
| Details |
1.Subjects already diagnosed with any serious systemic disorders which decline the general
condition and interfere with the course of the disease and its management. Such as Multiple
myeloma, Osteomalacia, Rickets, Bone disorders, Primary hyperparathyroidism, Metastatic
bone malignancy.
2. Subjects with blood pressure of systolic pressure more than 150 mm of Hg & Diastolic
pressure more than 100 mm of Hg. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in shoola,stambha |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in sandhi bandha shosha, bahupraspanditahara |
28 days |
|
|
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)
|
01/04/2025 |
| 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="2"
Months="0"
Days="0" |
|
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
|
This study is Randomized comparative clinical study to assess the efficacy of parinitakeriksheeradi taila nasya with vatari guggulu over masha taila with rasanadi guggulu in the management of Avabahuka that will be conducted in BLDEAS AVS Ayurveda Mahavidyalaya Hospital and Research Centre,Vijayapur - 586109 |