| CTRI Number |
CTRI/2021/09/036122 [Registered on: 01/09/2021] Trial Registered Prospectively |
| Last Modified On: |
29/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study to evaluate the effect of Mashabaladi Kwatha(Medicated Decoction) Nasapana(Nasapanal Administration)Followed By Prasaranyadi Kashaya (Medicated Decoction)In The Management Of Viswachi Vis-A-Vis Cervical Spondylosis |
|
Scientific Title of Study
|
A Clinical Study to Evaluate The Effect Of Mashabaladi Kwatha Nasapana Followed By Prasaranyadi Kashaya In The Management Of Viswachi Vis-A-Vis Cervical Spondylosis |
| 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 MONISHA |
| Designation |
PG SCHOLAR |
| Affiliation |
Sri Kalabyraveswara Swamy Ayurvedic Medical college Hospital and Research Centre Banglore |
| Address |
Dept of kayachikitsa room 2 Sri Kalabyraveswara Swamy Ayurvedic Medical college Hospital and Research Centre Banglore
Dept of kayachikitsa room 2 Sri Kalabyraveswara Swamy Ayurvedic Medical college Hospital and Research Centre Banglore
Bangalore
KARNATAKA
560104
India |
| Phone |
9447494574 |
| Fax |
|
| Email |
srmonishamsmi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ABDUL KHADER |
| Designation |
MD(AYU) PhD |
| Affiliation |
Sri Kalabyraveswara Swamy Ayurvedic Medical college Hospital and Research Centre Banglore |
| Address |
Dept of kayachikitsa room 2Sri Kalabyraveswara Swamy Ayurvedic Medical college Hospital and Research Centre 10 Pipeline road RPC Layout vijayanagar Banglore
Dept of kayachikitsa room2Sri Kalabyraveswara Swamy Ayurvedic Medical college Hospital and Research Centre 10 Pipeline road RPC Layout vijayanagar Banglore
Bangalore
KARNATAKA
560104
India |
| Phone |
9845199790 |
| Fax |
|
| Email |
Abukaya2003@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ABDUL KHADER |
| Designation |
MD(AYU) PhD |
| Affiliation |
Sri Kalabyraveswara Swamy Ayurvedic Medical college Hospital and Research Centre Banglore |
| Address |
Dept of kayachikitsa room no 2 Sri Kalabyraveswara Swamy Ayurvedic Medical college Hospital and Research Centre 10 Pipeline road RPC Layout vijayanagar Banglore
Dept of kayachikitsa room no 2 Sri Kalabyraveswara Swamy Ayurvedic Medical college Hospital and Research Centre 10 Pipeline road RPC Layout vijayanagar Banglore
Bangalore
KARNATAKA
560104
India |
| Phone |
9845199790 |
| Fax |
|
| Email |
Abukaya2003@gmail.com |
|
|
Source of Monetary or Material Support
|
| self,Dr.Monisha Sri Kalabyraveswara Swamy Ayurvedic Medical college Hospital and Research Centre 10 Pipeline road RPC Layout vijayanagar Banglore |
|
|
Primary Sponsor
|
| Name |
DR MONISHA |
| Address |
Sri Kalabyraveswara Swamy Ayurvedic Medical college Hospital and Research Centre Banglore |
| Type of Sponsor |
Research institution and hospital |
|
|
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 KIRAN M GOUD |
Sri Kalabyraveswara Swamy Ayurvedic Medical college Hospital and Research Centre Banglore |
Dept of kayachikitsa Room No 2 Sri Kalabyraveswara Swamy Ayurvedic Medical college Hospital and Research Centre 10 Pipeline road RPC Layout vijayanagar Banglore
Bangalore
KARNATAKA |
9845109556
kiranmgoud@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SKAMCHRC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M479||Spondylosis, unspecified. Ayurveda Condition: VISHWACHI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: prasaranyadi kashaya, Reference: sahasrayoga, Route: Oral, Dosage Form: Churna/ Powder, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: 30 Days, Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Intervention Arm | Procedure | - | nasapana | (Procedure Reference: chakradatta, Procedure details: POORVA KARMA–Bahya snehana in the form of Mrudu Abyanga with moorchitha taila is
done to urdwajatru pradesha, after snehana mild swedana should be done.
b) PRADHANA KARMA– Nasapana will be done in sitting posture. The head of the patient is
slightly elevated and with the help of left thumb patient’s nose raised simultaneously with the
right hand, the medicine 24 ml with time gap is poured into each nostril. Patient should spit
the medicine through mouth.
c) PASCHAT KARMA )
(1) Medicine Name: mashabaladi choorna, Reference: chakradatta, Route: Nasal, Dosage Form: Churna/ Powder, Dose: 24(g), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects of either Gender
Age group between 30- 70years
Lakshanas of Vishwachi
Signs and Symptoms of Cervical Spondylosis
Post covid and Non Covid patients
|
|
| ExclusionCriteria |
| Details |
Subjects with systemic diseases that may interfere with the course of treatment
Congenital and Neoplastic conditions of spine
Fracture or dislocation of Cervical region
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of Mashabaladi kwatha nasapana f/b by prasaranyadi kashaya in the management of viswachi vis a vis Cervical Spondylosis |
one half year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIl |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 |
|
Date of First Enrollment (India)
|
06/06/2022 |
| 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="7" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Viswachi is one among the Vataja nanatmaja vyadhi1.It affects the Kandara extending from Bahu prushta to Hasta and presenting mainly with pain radiating from Bahu prushta to hasta tala and Karma Kshaya of the bahu2. The Clinical presentation of Viswachi is similar to that of cervical spondylosis which is a degenerative condition of the cervical spine with clinical features of pain in neck, stiffness, radiating pain to the upper limb based on the progression and severity of the Disease. Cervical spondylosis is a common condition in occupational disorders specially related to software engineer, desktop workers, sedentary lifestyle, people are sitting for long duration. Everything now a days is automation and much more indulged in electronic gadgets. . The overall incidence of cervical spondylosis varies from 5% to 10%. As per the estimation, over the half of the adults experience some degree of neck pain every year and 60% to 80% of older adults experience neck pain due to degenerative changes4.Due to these particular cause this condition is more common in 30 -60 years of age group of people. As viswachi is a type of vata vyadhi. Nasapana with mashabaladi kwatha4 explained in chakradatta vatavyadhi chikitsa and also nasya is quite commonly used in this condition but nasapana is not commonly used in viswachi. Prasaranyadi Kashaya5 mentioned in sahasrayoga is indicated in vata vikara and apabahuka condition. This Kashaya which contains the following ingredients like prasarini, Masha, bala, rasona, rasna, shunti which acts on vata-kapha.Hence these interventions are taken for study. |