CTRI Number |
CTRI/2025/03/083062 [Registered on: 21/03/2025] Trial Registered Prospectively |
Last Modified On: |
20/03/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
|
A Comparative Clinical Study to evaluate the Efficacy of Patra Pinda Sweda and Churna Pinda
Sweda in the Management of Frozen Shoulder |
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE
EFFICACY OF PATRA PINDA SWEDA AND CHURNA PINDA
SWEDA IN THE MANAGEMENT OF AVABAHUKA W.S.R.
FROZEN SHOULDER |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Nitin Kumar |
Designation |
PG Scholar |
Affiliation |
Shri Shivayogeeshwar Rural Ayurvedic Medical College and Hospital |
Address |
PG Department of Panchkarma, Shri Shivayogeeshwar Rural Ayurvedic Medical College And Hospital, Inchal - 591102, Karnataka
Belgaum KARNATAKA 591102 India |
Phone |
8426805085 |
Fax |
|
Email |
nitintanwar58@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr G S Hadimani |
Designation |
Professor |
Affiliation |
Shri Shivayogeeshwar Rural Ayurvedic Medical College and Hospital |
Address |
PG Department of Panchkarma, Shri Shivayogeeshwar Rural Ayurvedic Medical College And Hospital, Inchal - 591102, Karnataka
Belgaum KARNATAKA 591102 India |
Phone |
9632755707 |
Fax |
|
Email |
gshadimani@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Akshay Shetty |
Designation |
Associate Professor |
Affiliation |
Shri Shivayogeeshwar Rural Ayurvedic Medical College and Hospital |
Address |
PG Department of Panchkarma, Shri Shivayogeeshwar Rural Ayurvedic Medical College And Hospital, Inchal - 591102, Karnataka
Belgaum KARNATAKA 591102 India |
Phone |
8892209106 |
Fax |
|
Email |
aksshetty402@gmail.com |
|
Source of Monetary or Material Support
|
Shri Shivayogeeshwar Rural Ayurvedic Medical College and Hospital, Inchala - 591102 |
|
Primary Sponsor
|
Name |
Shri Shivayogeeshwar Rural Ayurvedic Medical College and Hospital |
Address |
Shri Shivayogeeshwar Rural Ayurvedic Medical College and Hospital, Inchal - 591102 |
Type of Sponsor |
Private medical college |
|
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 G S Hadimani |
Shri Shivayogeeshwar Rural Ayurvedic Medical College and Hospital |
Shri Shivayogeeshwar Rural Ayurvedic Medical College and Hospital, Inchal, Karnataka - 591102 Belgaum KARNATAKA |
9632755707
gshadimani@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
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 | Comparator Arm | Procedure | - | Churna Pinda Sveda | (Procedure Reference: Keraliya Chikitsa Paddhati, Page 201, Procedure details: Churna Pinda Sweda is a herbal powder bolus fomentation therapy for Avabahuka (Frozen Shoulder). Medicated powders like Kolakulathadi Churna & Rasna Churna are heated in medicated oil, wrapped in a cotton cloth, & applied warm to the affected shoulder. The bolus is massaged in circular & linear strokes for 30-45 minutes per session. After therapy, the area is cleaned, & the patient is advised to rest, avoid cold exposure, & take a lukewarm bath. The treatment is done once daily for 8 days to relieve pain, stiffness, & restricted movement.)
| 2 | Intervention Arm | Procedure | - | Patra Pinda Sveda | (Procedure Reference: Keraliya Chikitsa Paddhati, Page 199, Procedure details: Patra Pinda Sweda is a herbal leaf bolus fomentation therapy for Avabahuka (Frozen Shoulder). Medicinal leaves like Nirgundi, Eranda, Chincha, Dhatura, Shigru, & Arka are fried in medicated oil, wrapped in a cotton cloth, & applied warm to the affected shoulder. The bolus is reheated & massaged in circular & linear strokes for 30-45 minutes per session. After therapy, the area is cleaned, & the patient is advised to rest, avoid cold exposure, & take a lukewarm bath. The treatment is done once daily for 8 days to relieve pain, stiffness, & restricted movement.)
|
|
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
Patient with pain in the Shoulder region (Amsha Sandhi Shoola) and restricted movements of the upper limb (Bahupraspandanhara).
Age - 20 to 70 years.
Both sex male/female.
Patients who are yogya for Swedana |
|
ExclusionCriteria |
Details |
Age below 20 years and above 70 years.
Patients having a history of surgical operation of the shoulder.
Patients with joint dislocation/fracture.
Patient with any systemic illness.
Pregnant women and lactating mothers.
Patients who are ayogya for Swedana. |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
To assess the efficacy of Patra Pinda Sweda and Churna Pinda Sweda in managing Avabahuka |
Duration of the treatment: 8 days.
Route of administration: External Application.
Dose: 30-45 minutes.
Follow up: on 15th day. |
|
Secondary Outcome
|
Outcome |
TimePoints |
To assess the efficacy of Swedana in managing Avabahuka |
Duration of Treatment: 8 days
Route of administration: External application
Dose: 30-45 minutes per session for 8 days
Follow-up: On the 15th day (7 days after completing treatment). |
|
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)
|
31/03/2025 |
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="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
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, a condition described in Ayurveda, closely resembles Frozen Shoulder (Adhesive Capsulitis) in modern medicine. It is characterized by pain, stiffness, and restricted movement of the shoulder joint, which worsens with activity and improves with rest. The prevalence of Frozen Shoulder in the general population ranges from 2-5%, with a higher incidence in individuals aged 40-60 years and those with diabetes or thyroid disorders. Avabahuka falls under Urdhvajatrugata Vata Vyadhi and is primarily a Vata-dominant disorder, though it can also have a Kapha association. When Vata Dosha is predominant, symptoms such as pain (Ruk), tingling (Spandan), pricking sensation (Tod), and numbness (Supti) are observed. If Kapha is also involved, symptoms like heaviness (Bharipan), drowsiness (Tandra), and loss of appetite (Aruchi) become prominent. The pathology is linked to Amsa Sandhi, where Vata provokes degeneration and Kapha depletion leads to dryness and stiffness, reducing joint lubrication. Swedana (sudation therapy) is a crucial treatment modality in Ayurveda for Vata disorders, and among its various types, Patra Pinda Sweda (herbal poultice fomentation) and Churna Pinda Sweda (powder bolus fomentation) are widely used. These therapies aim to reduce pain, improve mobility, and restore function. The study aims to compare the efficacy of Patra Pinda Sweda and Churna Pinda Sweda in the management of Avabahuka, as mentioned in classical texts, and evaluate their therapeutic benefits through a randomized comparative clinical trial. |