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CTRI Number  CTRI/2026/04/108342 [Registered on: 13/04/2026] Trial Registered Prospectively
Last Modified On: 13/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   clinical trail To Evaluate The Efficacy Of DashmulaBala Masha Ghrita And Dashmula Bala Masha Ksheera Nasapana In The Managment Of Avabahuka Frozen shoulder 
Scientific Title of Study   A Randomized Controlled Comparative Trail To Evaluate The Efficacy Of Diffrent Media Through Nasapana In The Managment Of Avabahuka (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  Dr Sayyed nizam ali akhlaque ali 
Designation  Pg scholar 
Affiliation  Ayurveda mahavidayalaya and hospital 
Address  Ayurveda mahavidayalaya and hospital extension heggeri hubli hubballi dharwad
department of panchakarma
Dharwad
KARNATAKA
580024
India 
Phone  9657653831  
Fax    
Email  sayyedniza546@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr sayyed nizam ali 
Designation  PG scholar 
Affiliation  Ayurveda Mahavidhyala HublAyurveda mahavidayalaya and hospitali 
Address  Ayurveda mahavidayalaya and hospital extension heggeri hubli hubballi dharwad
department of panchakarma
Dharwad
KARNATAKA
580024
India 
Phone  9657653831  
Fax    
Email  sayyedniza546@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Padmavati Venkatesh Kulkarni 
Designation  PG scholar 
Affiliation  Ayurveda Mahavidhyala HublAyurveda mahavidayalaya and hospitali 
Address  Ayurveda mahavidayalaya and hospital extension heggeri hubli hubballi dharwad
Department of panchakarma
Dharwad
KARNATAKA
580024
India 
Phone  9448235819  
Fax    
Email  padmavatikulkarni203@gmail.com  
 
Source of Monetary or Material Support  
ayurveda mahavidhayala heggeri old hubli karnataka 580024 india 
 
Primary Sponsor  
Name  Dr Sayyed Nizam Ali Akhlaque Ali 
Address  Ayurveda Mahavidyalaya Heggeri old hubli karnataka 580024 
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 Padmavati kulkarni  ayurveda mahavidyalaya and hospital   Department of Panchakrma
Dharwad
KARNATAKA 
9448235819

padmavatikulkarni203@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AYURVEDA MAHAVIDYALAYA & HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M354||Diffuse (eosinophilic) fasciitis. Ayurveda Condition: AVABA, (2) ICD-10 Condition:7||Osteopathic. Ayurveda Condition: AVABAHUKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-nasapana (Procedure Reference: chakradatta 22/26, Procedure details: dashmula bala masha ghrita nasapana fix dose 24ml each nostrilfor 7 days)
2Comparator ArmProcedure-nasapana (Procedure Reference: chakradatta 22/26, Procedure details: dashmula bala masha ghrita nasapana increasing dose start 12 ml each nostril increase 2 ml daily till 24 ml for 7 days)
3Comparator ArmProcedure-nasapana (Procedure Reference: chakradatta 22/26, Procedure details: dashmula bala masha ksheera nasapana fix dose 24ml each nostril for 7 days)
4Comparator ArmProcedure-nasapana (Procedure Reference: chakradatta, Procedure details: dashmula bala masha ksheera nasapana increasing dose start with 12 ml each nostril inceasing 2ml daily till 24ml each nostril for 7 days)
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Pain and stiffness in shoulder joint. (Sandhi Graha and Sandhi Shula)
Restricted range of motion of shoulder joint. (via Goniometer)
Localized Swelling. (Shotha)
1nd phase freezing duration (2 to 9 months)
2rd phase frozen duration (4 to 12 months)
3th phase Thawing duration (months to years)
Subjects who meet diagnostic criteria outlined above.
Individuals within age group of 30 to 70 years irrespective of gender.
Subjects assessed and found to be fit for undergoing Nasya.
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ExclusionCriteria 
Details  subject who unfit for nasya.
subject with condition that hinder proper administration of nasapana such as Grade 3 adenoids
Grade 3 DNS
Grade 3 nasal polyps
subject Diagnosed with Cervical Spondolysis
uncontrolled diabetes
Subject suffering from chronic debilitating illness such as tuberculosis. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
21 days  7 days 
 
Secondary Outcome  
Outcome  TimePoints 
50% relief  7 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 4 
Date of First Enrollment (India)   30/04/2026 
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 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  
NEED FOR THE STUDY
Panchakarma stands as foundational Ayurvedic therapeutic approach aimed at achieving
internal purification and restoring body’s physiological equilibrium. It comprises five specialized
modalities designed to expel accumulated dosha through nearest natural routes. In modern era,
healthcare is driven by evidence-based practices and measurable outcomes. There is pressing
need to integrate scientific rigor into traditional healing systems. Although Ayurveda emphasizes
individualized treatment and subjective evaluation, incorporation of objective methodologies.
Randomized controlled trials have its own importance due to its broader acceptance and
validation on global stage.
The present study focuses on clinical evaluation of single intervention in managing
Avabahuka in two different methods of preparation and administration: Dashamoola Bala Masha
Ghrita and Dashamoola Bala Masha Ksheera Nasapana with fixed and increasing dosage
schedule. Dashamoola Bala Masha Ksheera is noted herbal formulation with anti-inflammatory,
analgesic and Vata-balancing properties. Dashamoola Bala Masha Ghrita Nasapana indicated
for alleviating joint pain and stiffness.
This randomized controlled trial aims to evaluate efficacy of two formulations
systematically in alleviating symptoms of Avabahuka. Present study is planned to focus on
improving range of motion, reducing pain and enhancing functional recovery. The study will
provide valuable insights into clinical utility of these Ayurvedic formulations and to establish
evidence-based guidelines for their applicability in modern-day clinical practice.
Avabahuka is Vataja Vikara that hampers routine of individuals due to restricted range
of movements of shoulder joint. Avabahuka symptoms can be correlated to symptoms of
Adhesive capsulitis (frozen shoulder).
The worldwide incidence of Frozen shoulder is 2 to 5%. The prevalence is more among
diabetes and hypothyroidism between 40 and 60 years of age with prevalence of 76%. Women
are more often affected than men.1 In conventional medicine, NSAIDs and unaffordable surgical
procedures could not find perfect solution whereas implementation of Ayurvedic measures
proved better so far being effective and economical.
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Nasya is effective in Urdwajatrugata Vikara.2 Nasapana unique speciality of Nasya with
Dashamoola Bala Masha by virtue of Vatahara and Brihmana is indicated in Avabahuka.3
Earlier studies compared effects of Nasya and Nasapana in different diseases with same dosage
for seven days. Gradual increasing dosage schedule for Nasapana has been designed to assess
tolerance and patient compliance.
Various studies have evaluated efficacy of different Nasya and Nasapana formulations.
However, no comparative study has been conducted with Dashamoola Bala Masha Ghrita
Nasapana and Dashamoola Bala Masha Ksheera Nasapana. Randomized controlled trial is
justified to evaluate and compare efficacy of Dashamoola Bala Masha Ghrita Nasapana and
Dashamoola Bala Masha Ksheera Nasapana in the management of Avabahuka. The study aims
to fill gap in existing literature and contribute potentially formulation of evidence-based
Ayurvedic protocols for shoulder disorders.
 
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