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CTRI Number  CTRI/2025/02/080889 [Registered on: 19/02/2025] Trial Registered Prospectively
Last Modified On: 15/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare the effect of Krishana Mrittika lepa and Anu Tailam Pratimarsha nasya in management of Frozen shoulder. 
Scientific Title of Study   A randomised control trial to evaluate the efficacy of Krishana Mrittika lepa and Anu Tailam Pratimarsha nasya in managment of Avabahuka wsr to 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 Vandana 
Designation  PG Scholar 
Affiliation  Institute For Ayurved Studies and , Shri Krishna AYUSH University, Kurukshetra 
Address  Opd no 2, PG Department of Swasthavritta and Yoga,Institute for Ayurved Studies and Research,Shri Krishna Ayush University Sector 8 Umri Road

Kurukshetra
HARYANA
136118
India 
Phone  7419051021  
Fax    
Email  vandanasharma20122000@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vandana 
Designation  PG Scholar 
Affiliation  Institute For Ayurved Studies and , Shri Krishna AYUSH University, Kurukshetra 
Address  Opd no 2, PG Department of Swasthavritta and Yoga,Institute for Ayurved Studies and Research,Shri Krishna Ayush University Sector 8 Umri Road

Kurukshetra
HARYANA
136118
India 
Phone  7419051021  
Fax    
Email  vandanasharma20122000@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vandana 
Designation  PG Scholar 
Affiliation  Institute For Ayurved Studies and , Shri Krishna AYUSH University, Kurukshetra 
Address  Opd no 2, PG Department of Swasthavritta and Yoga,Institute for Ayurved Studies and Research,Shri Krishna Ayush University Sector 8 Umri Road

Kurukshetra
HARYANA
136118
India 
Phone  7419051021  
Fax    
Email  vandanasharma20122000@gmail.com  
 
Source of Monetary or Material Support  
Institute For Ayurved Studies and Research, Shri Krishna AYUSH University, Kurukshetra 136118 Haryana, India 
 
Primary Sponsor  
Name  Institute For Ayurved Studies and Research, Shri Krishna AYUSH University, Kurukshetra  
Address  Institute For Ayurved Studies and Research, Shri Krishna AYUSH University,Sector 8, Umri Road, Kurukshetra 136118 Haryana, India 
Type of Sponsor  Other [Government Ayurvedic 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 Seema Rani  Institute For Ayurved Studies & Research, Shri Krishna Ayush University Kurukshetra, Haryana  Opd no 2, PG Department of Swasthavritta and Yoga,Institute for Ayurved Studies and Research,Shri Krishna Ayush University Sector 8 Umri Road Kurukshetra Haryana 136118
Kurukshetra
HARYANA 
09466786108

seemaranimd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Shri Krishna AYUSH University, Kurukshetra  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-nAvanam, नावनम् (Procedure Reference: Astanga Hridyam, Procedure details: Anu Tailam Pratmarsha Nasya 2 Bindu in each nostril OD)
(1) Medicine Name: Anu Tailam, Reference: Astanga Hridyam, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 1(ml), Frequency: od, Duration: 28 Days
2Comparator ArmProcedure-lepa, लेप (Procedure Reference: Sarangdhar Samhita, Procedure details: After Mridu Swedana, Lepa of thickness 4-5 mm is applied and removed when dried, OD on alternate days)
(1) Medicine Name: Krishana Mrittika, Reference: Sarangdhar Samhita, Route: Topical, Dosage Form: Lepa Churna, Dose: 80(g), Frequency: od, Duration: 28 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients above the age of 18 years and below the age of 70 years.
Patient willing to participate in the clinical trial with signed consent form and will be once
informed orally and in writing of all the informations concerning the study procedure and
study objectives.
Patients with signs-symptoms of Frozen Shoulder are included in our study.
Patients of both genders (male/female)
Patients having chronicity less than 1 year duration. 
 
ExclusionCriteria 
Details  Patients under the age of 18 years and above the age of 70 years.
Patient with long term history of steroid and cytotoxic treatment.
Patients having history of any Chronic or systemic illness e.g. HTN, TB, Jaundice, Pregnant
and lactating women, Hernia, Eczema, Fungal infection, other skin diseases and underwent
recent abdominal surgeries.
Patient participated in any clinical trial within the last 6 months.
Auto immune disorders like SLE, RA etc.
Respiratory illnesses like bronchial asthma
Dislocation of Shoulder joint.
Uncontrolled metabolic disorders like Diabetes mellitus. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Patient having relief in symptoms of frozen shoulder like Improved degree of movement and rotatios.
The assessment of progress will be observed after 28 days, after completion of the course of treatment.
An assessment scale is a frame to assess the rate of improvement. At the end of the
treatment the percentage of relief is calculated by Goniometer. 
follow up for subjective and objective criteria will be once in a week for 28 days. 
 
Secondary Outcome  
Outcome  TimePoints 
Associated relief in symptoms like pain, stiffness, etc.
Shirshool, Khalitya, Palitya, seasonal cough cold, etc. 
follow up for subjective & objective criteria will be once in a week for 28 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 2/ Phase 3 
Date of First Enrollment (India)   01/03/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  
 Ayurveda is the ancient traditional system of medicine and oldest holistic healing art. Since the time has been known, Ayurveda is showing the ideal way of living, which promises a disease free, happy and long life. All branches of Ayurveda have depth of knowledge in concise form. Elaborating the ideas and doing research on basic principles of Ayurveda, is the need of the present era. Avabahuka is a disease that affects the Amsa Sandhi (shoulder joint) and is caused by the Vata Dosha. Even though the term Avabahuka is not mentioned in the Nanatmaja Vata Vyadhi, Acharya Sushruta and others have considered Avabahuka as a Vata Vyadhi. Bahu Shosha can be considered as the preliminary stage of the disease where loss or dryness of the Shleshaka Kapha. Due to this anti-inflammatory property of Krishana Mrittika, its lepa is benefecial in managment of frozen shoulder. It has been mentioned in chikitsa sutra of avabahuka according to Acharaya Charaka and Acharya Sushruta Snehika Nasya is indicated for Avabahuka. The aim of the present study was to evaluate the effectiveness of Nasya karma on Avabahuka. Sukshama Vyayama ( will be advised to both groups) (Wrist movement, Elbow movement, Shoulder movement, Neck movement, Wall climbing exercises, Towel stretch exercises); Chakki challan; Asanas (Tadasana, Ardhakatichakrasana, Katichakrasna, Shashankasana) and Pranayama (Kapalbhati, Anulom-Vilom, Bhramri) will advised to patient.
 
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