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CTRI Number  CTRI/2023/07/055319 [Registered on: 18/07/2023] Trial Registered Prospectively
Last Modified On: 17/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of therapeutic Tarpan Nasya( Nasal Oiling)with Karpasasthayadi taila and Dashmoolyadi kwatha(medicated decoction) in Frozen shoulder (Avabahuka). 
Scientific Title of Study   A Comparative Clinical Study Of Tarpan Nasya With Karpasasthayadi Taila And Dashmoolyadi Kwatha Pana In Avabahuka With Special Reference To Frozen Shoulder 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ajay Kumar Gupta 
Designation  MD Scholar (Panchakarma) 
Affiliation  Government P.G Ayurveda College and Hospital Varanasi U.P 
Address  OPD No. 8 Department of Panchakarma, Government PG Ayurveda College and Hospital Varanasi

Varanasi
UTTAR PRADESH
221002
India 
Phone  9792372531  
Fax    
Email  ajaykumarguptabhu777@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Padma Lochan Sankhua 
Designation  Reader and HOD Department of Panchakarma 
Affiliation  Government P.G Ayurveda College and Hospital Varanasi U.P 
Address  OPD No 8 Department of Panchakarma, Government PG Ayurveda College and Hospital, Varanasi

Varanasi
UTTAR PRADESH
221002
India 
Phone  7376468851  
Fax    
Email  pls_bls@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ajay Kumar Gupta 
Designation  MD Scholar (Panchakarma) 
Affiliation  Government P.G Ayurveda College and Hospital Varanasi U.P 
Address  OPD No 8 Department of Panchakarma, Government PG Ayurveda College and Hospital Varanasi

Varanasi
UTTAR PRADESH
221002
India 
Phone  9792372531  
Fax    
Email  ajaykumarguptabhu777@gmail.com  
 
Source of Monetary or Material Support  
Government P.G. Ayurveda College and Hospital,Varanasi, U.P. 
 
Primary Sponsor  
Name  Government PG Ayurveda College and Hospital Varanasi UP 
Address  Department of Panchakarma, Government PG Ayurveda College and Hospital, Varanasi,U.P. 
Type of Sponsor  Government 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 Ajay Kumar Gupta  Government PG Ayurveda College and Hospital, Varanasi, U.P.  Department of Panchakarma, Government PG Ayurveda College and Hospital Varanasi,U.P.
Varanasi
UTTAR PRADESH 		 9792372531

ajaykumarguptabhu777@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC,GOVERNMENT AYURVEDA COLLEGE AND HOSPITAL ,VARANASI,U.P,MAHAYOGI GURU GORAKHNATH AYUSH UNIVERSITY,GORAKHPUR,U.P  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
1Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: chakradutt nasyadhikar chapter 8, Procedure details: Nasya karma with Karpasasthyadi taila 8 drops in each nostril in the morning once daily for 27 days in 3 sittings of 7 days with 3 days gap)
(1) Medicine Name: karpasasthyadi taila, Reference: sahastrayog taila prakaran, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 27 Days
2Comparator ArmDrugClassical(1) Medicine Name: Dasmoolyadi Kwath, Reference: Chakradutta vatvyadhi chikitsa prakaran shlok 25, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 27 Days, anupAna/sahapAna: No, Additional Information: Patient is given nasya of Karpasasthyadi taila along with Dashmoolyadi Kwath.
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients will be selected irrespective of sex, occupation, caste, etc. The patients between age of 30 to 70 years will be included in the study. Patients with classical signs and symptoms of Avabahuka will be included .(Ash.H.Ni-15/43) & (Sh.Ni-1/82)
Amsa Sandhi Shoola - shoulder pain.
Amsa Stabdhata - shoulder stiffness.
Bahupraspandanam - Restriction in the movement of shoulder joint. 
 
ExclusionCriteria 
Details  1.Auto immune disorder like SLE,RA etc.
2.Post Traumatic injuries ,fractures.
3.Dislocation of Shoulder joint.
4.Underlying illness such as Uncontrolled Thyroid diseases,Diabeties mellitus,hyper lipidemia and Tuberculosis. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Relief from essential symptoms like shoulder pain, stiffness, & in the movement of shoulder joint.  14 days 
 
Secondary Outcome  
Outcome  TimePoints 
relief in pain & stiffness and full movement of shoulder   27days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 3/ Phase 4 
Date of First Enrollment (India)   28/07/2023 
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   Clinical study:
Patients will be selected from the OPD and IPD of the Government Ayurvedic College and Hospital ,Varanasi.
1.Inclusion criteria :
    Patients will be selected irrespective of sex, occupation, caste ,etc
    The patients between age of 30 to 70 years will be included in the study.
    Patients with classical signs and symptoms of Avabahuka will be included.i.e,
  • Amsa Sandhi Shoola -shoulder pain.
  • Amsa Stabdhata - shoulder stiffness.
  • Bahupraspandanam-Restriction in the movement of shoulder joint.     
2.Exclusion criteria:
  • Auto immune disorders like SLE,RA etc.
  • Post Traumatic injuries, fractures.
  • Dislocation of Shoulder joint.
  • Underlying illness such as Uncontrolled Thyroid disease, Diabetes mellitus, hyper lipidemia  and Tuberculosis.
3.Groups:

Group A:
         In this group 30 patients will be treated with Nasya with Karpasasthyadi Taila.
         Duration of Nasya =27 days in 3 sittings of 7days with 3 days gap
         Follow Up = 35th day
        Total duration of trial= 35days
Group B:
          In this group 30 patients will be subjected to both Nasya with Karpasasthayadi Taila along with the Dashmoolyadi Kwatha Pana (50ml)
          Nasya Duration -27 days(3 sitting of 7 days with 3 days gap)
          Kwatha Pana Duration=27days
           Follow Up = D35th
           Total duration of trial= 35days

           
4.Assessment criteria:
          The study will be carried out for 35 days.the patients will be assessed on day 1,day 15th,day 27th and day 35th on the basis of symptoms.

5.Statistical analysis method :
          the parameters of baseline will be compared with the follow-up status for the assessment of results.       
 
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