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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M750||Adhesive capsulitis of shoulder. Ayurveda Condition: AVABAHUKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-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.)
2Intervention ArmProcedure-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.

 
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