| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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 | | 2 | Comparator Arm | Procedure | - | 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. |