| CTRI Number |
CTRI/2024/04/065182 [Registered on: 04/04/2024] Trial Registered Prospectively |
| Last Modified On: |
26/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical trial to study the efficacy of Hruswapanchamula Taila as Nasya and Uttarabhaktika Snehapana in subjects of Avabahuka vis-a-vis Frozen Shoulder |
|
Scientific Title of Study
|
A Comparative Clinical Study to Evaluate the Efficacy of Nasya and Uttarabhaktika Snehapana with Hruswapanchamula Taila in the Management of Avabahuka vis-a-vis 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 Spoorthi UB |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda Medical College, Mysuru |
| Address |
Department of Panchakarma, Government Ayurveda Medical College, Visvesvaraya Circle, Devaraja Mohalla, Mandi Mohalla
Mysore
KARNATAKA
570001
India |
| Phone |
8296313950 |
| Fax |
|
| Email |
spoorthiub95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varsha kulkarni |
| Designation |
Professor and HOD |
| Affiliation |
Government Ayurveda Medical College, Mysuru |
| Address |
Department of Panchakarma, Government Ayurveda Medical College, Visvesvaraya Circle, Devaraja Mohalla, Mandi Mohalla
Mysore
KARNATAKA
570001
India |
| Phone |
7676848402 |
| Fax |
|
| Email |
kulkarnidrvarsha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Spoorthi UB |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda Medical College, Mysuru |
| Address |
Department of Panchakarma, Government Ayurveda Medical College, Visvesvaraya Circle, Devaraja Mohalla, Mandi Mohalla
Mysore
KARNATAKA
570001
India |
| Phone |
8296313950 |
| Fax |
|
| Email |
spoorthiub95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda Medical College, Visveshwaraya Circle, Devaraja Mohalla, Mandi Mohalla, Mysuru, Karnataka570001 |
|
|
Primary Sponsor
|
| Name |
Dr Spoorthi UB |
| Address |
Department of Panchakarma, Government Ayurveda Medical College, Visvesvaraya Circle, Devaraja Mohalla, Mandi Mohalla |
| Type of Sponsor |
Other [Self] |
|
|
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 Spoorthi UB |
Government Ayurveda Medical College & Hospital, Mysuru |
Room no-14, Government Ayurveda Medical College & Hospital,
Mysore
KARNATAKA |
8296313950
spoorthiub95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - Government Ayurveda Medical College & Hospital, Mysuru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M750||Adhesive capsulitis of shoulder. Ayurveda Condition: AVABAHUKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | AByantarasnehaH , आà¤à¥à¤¯à¤¨à¥à¤¤à¤°Â सà¥à¤¨à¥‡à¤¹à¤ƒ | (Procedure Reference: Ashtanga Hrudaya Chikitsa 21/44, Procedure details: Poorvakarma: Deepana pachana with Chitrakadi vati 250mg BD before food with luke warm water till attainment of Nirama lakshana
Pradhanakarma: Uttarabhaktika Snehapana with Hruswapanchmoola taila 15ml immediately after food (Morning & Evening) with ushnajala anupana for 7 days
Pashchat karma: Ushna jalapana till snehajeerna lakshanas observed)
(1) Medicine Name: Hruswapanchamoola Taila, Reference: Charaka Samhita Chikitsa Sthana 28/138-141, Route: Oral, Dosage Form: Taila, Dose: 15(ml), Frequency: bd, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Ashtanga Hrudaya Chikitsa Sthana 21/44, Procedure details: Poorvakarma: Deepana pachana with Chitrakadi vati 250mg BD before food with luke warm water till attainment of Nirama lakshana
Urdhvajatru Abhyanga with ksheerabala taila followed by pata sweda
Pradhanakarma: Nasya with Hruswapanchmoola taila -8 Bindu (4ml) in each nostril for 7 days,will be done during early morning in an empty stomach
Pashchat karma: Kavala with ushnajala & Dhumapana.)
(1) Medicine Name: Hruswapanchamoola taila, Reference: Charaka Samhita Chikitsa Sthana 28/138-141, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects fulfilling the Diagnostic criteria.
2. Subjects between the age group of 25-60 years, irrespective of gender.
3. Subjects fit for Snehapana and Nasya Karma. |
|
| ExclusionCriteria |
| Details |
1. Subjects with the history of fracture and dislocation of shoulder joint.
2. Subjects suffering from any other systemic disorders which interferes with the course of intervention.
3. Subjects having HbA1c more than 7.65
4. Pregnant women and lactating mothers.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of Nasya with Hruswapanchamoola taila in reducing pain as well as stiffness and improvement in the Range of Movement. |
8th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Efficacy of Nasya & Uttarabhaktika Snehapana with Hruswapanchamoola taila in improving the range of motion of the affected shoulder joints by comparing the readings of Goniometer before & after the intervention. |
8thday 15thday |
|
|
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 3 |
|
Date of First Enrollment (India)
|
15/04/2024 |
| 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 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
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF NASYA
AND UTTARABHAKTIKA SNEHAPANA WITH HRUSWAPANCHAMULA TAILA IN THE MANAGEMENT OF AVABAHUKA VIS-A-VIS FROZEN
SHOULDER. Sneha is described as the essence
of Purusha i.e, “Snehasro Ayam Purusha: Pranascha Snehabhuyishtaha1â€.
In Panchakarma, Snehana can be administrated either as Pradhana Karma (Brumhana
Snehapana) and (Shamana Snehapana) or can be done as Poorvakarma (Shodhanartha Snehapana)
before Shodhana Therapy. Brumhana kind of
Snehana can be administered as Panartha and as well as Nasya , which are found to be effective in vatavyadhi2. Avabahuka is one among the vataja
nanatmaja Vyadhi affecting Amsapradesha having symptoms like Shula, Sthamba, Bahupraspandanahara3.These
symptoms resembles with the Symptoms of Frozen Shoulder. Frozen shoulder is characterized
by pain and restricted movements of the shoulder usually in the absence of
intrinsic shoulder disease4. The prevalence rate of Frozen
shoulder globally is around 2-5%.In Indian population it ranges between 15-25%,
among Subjects with Diabetes mellitus 3-6% encounter frozen shoulder5.
Contemporary treatment for frozen shoulder includes oral
NSAIDS, Corticosteroids, External therapies like Hot and cold compression packs6
gives symptomatic relief without targeting the root cause. In classics the
treatment for Avabhahuka includes Nasya and Uttarabhaktika Snehapana7,
Swedana8 and Nasapana9. Nasya and Uttarabhaktika Snehapana are the two important procedures which are
specially indicated in Urdhvajatrugata Vatavikaras. Uttarabhaktika Snehapana is
a type of Brumhana snehapana. Where administered Sneha immediately after food
gives strength to Urdhvajatru Pradesha. The dose of Bruhmana Snehapana is Alpa matra10,
Nasya is the therapeutic procedure in which the administered intranasal drug
strengthens the Urdhvajatru Avayava and eliminate the aggravated Doshas11. Hence
the present study aims to compare the procedural efficacy
of Nasya and Uttarabhaktika Snehapana with Hruswapanchamula Taila12 which
is directly indicated in Vata and Kaphanubandha Vatavyadhi. having the properties
like Madhura, Brumhana and Vata-Kaphahara which counteract the pathology of the
Avabahuka Vis-A-Vis Frozen Shoulder. |