| CTRI Number |
CTRI/2025/02/080932 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
13/02/2025 |
| 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
|
Treatment of Adhesive capsulitis disease symptoms such as Pain, stiffness in shoulder and restricted movements of shoulder joint etc, using Ayurvedic formulations |
|
Scientific Title of Study
|
A randomized controlled clinical study to evaluate the combined efficacy of Asitakadi churna internally with Koladi churna lepa over Trayodashanga guggulu with Koladi churna lepa in Avabahuka with special reference to Adhesive Capsulitis |
| 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 Soujanya |
| Designation |
PG Scholar |
| Affiliation |
Shri DGM ayurvedic medical college, kalsapur road, shivanand nagar Gadag. 582103 |
| Address |
Dr Soujanya Dept of Kaychikitsa opd number 03
Gadag
KARNATAKA
582103
India |
| Phone |
9606659300 |
| Fax |
|
| Email |
soujanyabams123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrShettar RV |
| Designation |
Professor |
| Affiliation |
Shri DGM ayurvedic medical college, kalsapur road, shivanand nagar Gadag. 582103 |
| Address |
Dr.Shettar R.V Dept of kayachikitsa opd number 03
Gadag
KARNATAKA
582103
India |
| Phone |
9845613116 |
| Fax |
|
| Email |
shettar_dr@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soujanya |
| Designation |
PG Scholar |
| Affiliation |
hri DGM ayurvedic medical college, kalsapur road, shivanand nagar Gadag. 582103 |
| Address |
Dr Soujanya Dept of Kaychikitsa opd number 03
Gadag
KARNATAKA
581203
India |
| Phone |
9606659300 |
| Fax |
|
| Email |
soujanyabams123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri DGM Ayurvedic Medical College And Hospital Gadag 582103 |
|
|
Primary Sponsor
|
| Name |
Dr Soujanya |
| Address |
DGM Ayurvedic Medical College And Hospital PG PhD centre Kalsapur Road, Shivanand Nagar Gadag. 582103 |
| 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 |
| DR SOUJANYA |
Shri DGM Ayurvedic Medical College and hospital. |
Kaya chikitsa OPD, room number 03
Gadag
KARNATAKA |
9606659300
soujanyabams123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DGM AYURVEDIC MEDICAL COLLEGE ETHICAL CLEARNCE COMMITTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M678||Other specified disorders of synovium and tendon. Ayurveda Condition: AVABAHUKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Asitakadi churna, Reference: Bhavaprakasha Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Ushnajala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Trayodashanga guggulu, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Guggulu , Dose: 1000(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Sukoshnajala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.All cases of clinical sign and symptoms of Avabahuka like Bahushula, Bahustabdata, and Bahuspandanahara and the signs and symptoms of Adhesive capsulitis such as pain, stiffness and restricted movements of shoulder joint.
2.Subjects of age group 30 to 70 years.
3.Subjects of both gender
4.Duration of disease upto 1 year
5.Subjects who are willing to participate and gives written consent
|
|
| ExclusionCriteria |
| Details |
1. Pregnant women and Lactating Mother
2.Subjects with shoulder dislocation and fracture
3.Systemic diseases such as uncontrolled Diabetes mellitus, Hypertension and Thyroid dysfunction
|
|
|
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 of signs and symptoms like, shula , stamba, Bahuspanditahara , Amsabandana shosha with special reference to Adhesive capsulitis . |
15 Days |
|
|
Secondary Outcome
|
|
|
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 4 |
|
Date of First Enrollment (India)
|
28/02/2025 |
| 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 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
|
Avabahuka is a
disease of Amsasandhi( shoulder
joint) it has been described under
Vatavyadhi by Acharya Sushruta, Vaghbata, Vangasena, Madhavakara and other acharyas. Being a disease of Shoulder
joint which has greatest range of motion , it
is of vital importance to the activities of daily routine and work, this
disease is hindrance to one’s
productivity. In contemporary science it can be
correlated to Adhesive capsulitis, characterised by pain and restricted movements of shoulder in the absence of
intrinsic shoulder disease, Night
pain is often present in affected shoulder, Adhesive capsulitis may follow
Bursitis, tendonitis of the shoulder.
Treatment for Adhesive capsulitis in modern medicine are Local injections of Glucocorticoids and NSAIDS, Long term use of
these may leads to some side effects. Lot of studies have been conducted on
Avabahuka which have shown efficacy of Nasya, Jambirapinda sweda, Uttarabaktika snehapana, and Shamanoushadi in the treatment of Avabahuka. Koladi churna lepa is considered as one of the
treatments for Vatavyadhi as explained
in Vangasena samhita Vatavyadhi
adhikara.
Till now very few studies
are conducted on lepa in treatment of Avabahuka, This Koladi Churna contains herbal drugs which are cost effective, safe and therapeutically possess Vatakaphahara, Shulahara
and Anti-inflammatory effects.
Asitakadi churna explained
in Bhavaprakasha nighantu
Madyamakanda in Amavata
prakarana has direct indication in Avabahuka, it has
properties like Vatakaphahara, Shulahara, and Anti-inflammatory. Hence, Koladi choorna
lepa externally with Asitakadichurna internally are chosen for the study |