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CTRI Number  CTRI/2025/08/092628 [Registered on: 07/08/2025] Trial Registered Prospectively
Last Modified On: 07/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study conducted to see the effect of Svalpa Masha Taila Nasya and Vishwadi Kashaya in stiffness of shoulder 
Scientific Title of Study   Controlled clinical study to evaluate the effect of Svalpa Masha Taila Nasya and Vishwadi Kashaya in 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  Ameena Shireen  
Designation  M.D second year 
Affiliation  Rajarajeshwari Ayurvedic Medical College Hospital And PG centre 
Address  Sitara palace noorkhan taleem opposite Mumtaz function hall Bidar
Department of Kayachikithsa Room no. 3 1st floor Rajarajeshwari Ayurvedic Medical College Hospital And PG centre , Humnabad 585330
Bidar
KARNATAKA
585401
India 
Phone  7338665786  
Fax    
Email  ameenaphool5049@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. PRADEEP B C 
Designation  Associate Professor, Dept of Kayachikithsa 
Affiliation  Rajarajeshwari Ayurvedic Medical College Hospital And PG centre 
Address  Dept of Kayachikithsa, Room No. 3 , 1st floor Rajarajeshwari Ayurvedic Medical College Hospital And PG centre , Humnabad 585330
Dept of Kayachikithsa, Room No. 3 1st floor Rajarajeshwari Ayurvedic Medical College Hospital And PG centre , Humnabad 585330
Bidar
KARNATAKA
585401
India 
Phone  7795074630  
Fax    
Email  bcpradeep077@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrB Alivelu Manga 
Designation  Professor 
Affiliation  Rajarajeshwari Ayurvedic Medical College Hospital and P.G centre Humnabad 585330 
Address  Dept of Kayachikithsa, Room No. 3 1st floor Rajarajeshwari Ayurvedic Medical College Hospital And PG centre , Humnabad 585330
Dept of Kayachikithsa, Room No. 3 1st floor Rajarajeshwari Ayurvedic Medical College Hospital And PG centre , Humnabad 585330
Bidar
KARNATAKA
585330
India 
Phone  9848199778  
Fax    
Email  dralivelumanga@yahoo.in  
 
Source of Monetary or Material Support  
Rajarajeshwari Ayurvedic Medical College Hospital and P.G centre Humnabad 585330 
 
Primary Sponsor  
Name  Rajarajeshwari Ayurvedic Medical College Hospital and PG centre Humnabad 
Address  Rajarajeshwari Ayurvedic Medical College Hospital and P.G centre Humnabad, District Bidar , Karnataka , India pin code- 585330 
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 Ameena Shireen  Rajarajeshwari Ayurvedic Medical College Hospital and P.G Centre  Dept of Kayachikithsa Room no. 3 1st floor Rajarajeshwari Ayurvedic Medical College Hospital and P.G Centre Humnabad 585330
Bidar
KARNATAKA 
7338665786

ameenaphool5049@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC Rajarajeshwari Ayurvedic Medical College Hospital and P.G centre Humnabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: AVABAHUKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Charaka Samhita by Acharya Vidyadhar Shukla and Prof . Ravi Dutt Tripathi Chikitsa Sthana Vatavyadhi Chikitsa Adhyaya chapter no : 28 chaukhamba Sanskrit pratishthan publishers Pg no : 704 Shloka no : 98., Procedure details: 8 drops (4 drops in each nostril) for 7 days )
(1) Medicine Name: Svalpa Masha taila, Reference: Cakradatta chikitsa sangraha of chakrapanidatta by Dr R.vidyanath and Dr.K.nishteswar, , Cakradatta Chikitsa Adhyaya :Vatavyadhi Adhyaya chapter no: 22 chaukhambha prakashan Varanasi edition 2022 Pg no : 175 Shloka no : 55, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 8(drops), Frequency: od, Duration: 7 Days
2Comparator ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: Charaka Samhita by Acharya Vidyadhar Shukla and Prof . Ravi Dutt Tripathi Chikitsa Sthana Vatavyadhi Chikitsa Adhyaya chapter no : 28 chaukhamba Sanskrit pratishthan publishers Pg no : 704 Shloka no : 98., Procedure details: 8 drops (4 drops in each nostril ) for 7 days )
(1) Medicine Name: Karpasasthyadi taila, Reference: Sahasrayogam by Dr.G.Prabhakara Rao , Taila yoga prakaranam chapter no :18 chaukhambha publications new delhi ,reprint 2021 Pg no : 479 Shloka no :22., Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 8(drops), Frequency: od, Duration: 7 Days
3Intervention ArmDrugClassical(1) Medicine Name: Vishwadi kashaya, Reference: Sahasrayogam by DR.G.Prabhakara Rao , Kashaya yoga prakarana chapter no : 3 chaukhambha publications new delhi ,reprint 2021 pg no:192 Shloka no : 417., Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -ushna jala), Additional Information: -
4Comparator ArmDrugClassical(1) Medicine Name: Dasamuladi kashaya, Reference: Sahasrayogam by Dr .G.Prabhakara Rao , kashaya yoga prakarana chapter no : 3 chaukhambha publications new delhi ,reprint 2021 Pg no : 76 Shloka no : 156., Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -ushna jala), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with Shoola and Bahupraspandahara in shoulder joint.
Patients between the age group of 20-60 years were selected irrespective of sex.
Patients fit for Nasya.
Patients with classical features of Avabahuka mentioned in the method of collection of data. 
 
ExclusionCriteria 
Details  Patients below the age of 20 and above the age of 60 years are excluded.
Pregnant and lactating women.
Patients with the history of fracture and any external injury. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFECT OF SVALPA MASHA TAILA NASYA AND VISHWADI KASHAYA IN AVABAHUKA  7 days 
 
Secondary Outcome  
Outcome  TimePoints 
Aims and objectives of the study
1. To evaluate the efficacy of Svalpa Masha Taila Nasya with Vishwadi Kashaya in Avabahuka.
2. To evaluate the efficacy of Karpasasthyadi Taila Nasya with Dasamuladi Kashaya in Avabahuka.
3. To evaluate and compare the efficacy of Svalpa Masha Taila Nasya and Vishwadi Kashaya with
Karpasasthyadi Taila Nasya and Dasamuladi Kashaya in Avabahuka. 
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   N/A 
Date of First Enrollment (India)   20/08/2025 
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 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  

Vata is considered as a chief factor for the physiological maintenance of the body. Factors provoking

Vata results in the instantaneous manifestation of diseases. Amongst all the Vata Vyadhis our Acharyas

have described, Avabahuka is one such disease that has direct impact on the day to day activity of an

individual .

Avabahuka is considered to be an Urdhvajatrugata Vata Vikara (disorders due to vitiated Vata Dosha

above the collar bone) which impairs the normal functioning of the upper limb.India being a developing

nation comprising of hardworking agriculturists ,labourers etc. and hence the incidence of Avabahuka is

relatively high.

In the classics , Avabahuka is a disease characterised by morbid Vata Dosha localizing around the Amsa

Pradesha and thereby causing Shoshana of Amsa Bandha as well as Akunchana of Siras at the site.

Incidence rate of this disease is 3-5% in general citizens, the incidence increases upto 20% with diabetic

patients. Incidence of opposite shoulder affected once first one has resolved is around 6-17%.

lifetime prevalence of Avabahuka is estimated to be 2-5% of general population. Avabahuka was found

to effect 8.2% of men and 10.1% of women of working age. The condition is more common in 5th and

6th decades of life, with the peak age in the mid: - 50s.

Avabahuka in modern can be correlated with frozen shoulder a painful condition that causes fibrosis of

the gleno-humeral joint capsule is accompanied by progressive stiffness and restriction of range of

movements.

The causes (Hetu) of Avabahuka may be classified into two groups. (i) Bahya Hetu — Causing injury to

the vital parts of the body (Marma) or the region surrounding the Amsa Sandhi, which is also known as

Bahya Abhigataja that manifests the Vyadhi or disease first; (ii) Abhyantara Hetu — Indulging in the

etiological factors that aggravate Vata leading to the vitiation of vata in that region and is also known as

Dosha Prokopajanya, which in turn leads to Karmahani of Bahu.

In today’s life both these Hetus are seen in the formation of Avabahuka.

This study aims at searching an easily available, affordable and effective treatment modality for

Avabahuka .

In Ayurveda Chikitsa of Avabahuka is already established. Chikitsa Sutra of Avabahuka includes nasya

and Uttarabhaktika Snehapana . Astanga Hridaya mentions Nasya and Sneha Pana for Avabahuka.

Sushrutacharya advises Vatavyadhi Chikitsa for Avabahuka, except Siravyadha.

Chikitsa Sara Sangraha advises Nasya, Uttara Bhaktika Snehapana, and Sweda for the treatment of Avabahuka.

By considering the above references, Nasya and Uttara Bhaktika Snehapana are the standard line of

treatment in the management of Avabahuka. In this study we are concentrating on Nasya.

This research work on Avabahuka , contributes to improve the quality of life and by virtue of this

present study we aim to evaluate and compare the efficacy of trial drug Svalpa Masha Taila Nasya and

Vishwadi Kashaya with standard drug Karpasasthyadi Taila Nasya and Dasamuladi Kashaya.

Therefore an attempt will be made to evaluate and compare the efficacy of trial and standard drugs in

Avabahuka.


 
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