| CTRI Number |
CTRI/2025/03/082494 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
14/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of suddha bala taila nasya in the manyastambha(Neck Stiffness ) |
|
Scientific Title of Study
|
Observational study to evaluate the efficacy of suddha bala taila nasya in the management of manyastambha |
| 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 Sphurti Popat Mali |
| Designation |
PG scholar |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya Gadhinglaj |
| Address |
LKR Ayurvedic mahavidyalay Post Graduate training and Research centre Gadhinglaj
P2 MIDC area Shendri Mall Gadhinglaj Kolhapur pin 416502
Panchakarma Department ground floar room no 3 LKR Hospital P2 MIDC area Shendri Mall Gadhinglaj Kolhapur pin 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
8806369889 |
| Fax |
|
| Email |
malisphurti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namrata Shirsath |
| Designation |
Associate Professor of Panchakarma Department |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya Gadhinglaj |
| Address |
LKR Ayurvedic mahavidyalay Post Graduate training and Research centre Gadhinglaj
P2 MIDC area Shendri Mall Gadhinglaj Kolhapur pin 416502
Panchakarma Department ground floar room no 3 LKR Hospital P2 MIDC area Shendri Mall Gadhinglaj Kolhapur pin 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
7798861414 |
| Fax |
|
| Email |
namishirsat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namrata Shirsath |
| Designation |
Associate Professor of Panchakarma Department |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya Gadhinglaj |
| Address |
LKR Ayurvedic mahavidyalay Post Graduate training and Research centre Gadhinglaj
P2 MIDC area Shendri Mall Gadhinglaj Kolhapur pin 416502
Panchakarma Department ground floar room no 3 LKR Hospital P2 MIDC area Shendri Mall Gadhinglaj Kolhapur pin 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
7798861414 |
| Fax |
|
| Email |
namishirsat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Panchakarma Department ground floar room no 3 LKR Hospital P2 MIDC area Shendri Mall Gadhinglaj Kolhapur pin 416502 country India |
|
|
Primary Sponsor
|
| Name |
Dr Sphurti Popat Mali |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya Gadhinglaj Kolhapur Country India
pin 416502 |
| 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 Sphurti Popat Mali |
Late Kedari Redekar Ayurvedic College And Research Center Gadhinglaj |
Panchakarma Department ground floar room no 3 LKR Hospital P2 MIDC area Shendri Mall Gadhinglaj Kolhapur pin 416502
Kolhapur
MAHARASHTRA |
8806369889
malisphurti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Late Kedari Redekar Ayurvedic Mahavidyalaya Gadhinglaj Kolhapur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G328||Other specified degenerative disorders of nervous system in diseases classified elsewhere. Ayurveda Condition: MANYASTAMBAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Ashtangahridayam , Procedure details: Poorva Karma
Instruments collection
Consent form
Preparation of patient
Abhyang & Sweda should be given to patient instead of Uttamanga with Koshna Taila
Position of patient
Supine position given to patient
Head slightly extended up to 45 degree
Pradhan Karma
Matra 4 ml in each nostril
After fulfilling all the pre-requirements eyes of the patient are covered with Chaturguna Vastra
The medication to be administered is placed in a vessel made of Mrut Patra & then made lukewarm by placing it in a vessel containing hot water later tip of patients nose is drawn upward by the Vama Pradeshni & with the Dakshina Hasta the lukewarm medicament is instilled into both nostrils using dropper
The medicine is administered to both nostrils in an Avichinadhara one after the other keeping one nostril closed while the other is instilled with medicine
The patient should remain relaxed during & after the time of administration of Nasya
Pashchat Karma
Nishtivan
Mardana sweda
Dhoompana & Kavala
Parihar
)
(1) Medicine Name: Shuddha Bala Taila , Reference: Sahatrayogam , Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 4(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having all socio economic status
Patients having symptoms of manyastambha
Those who are fit for Nasya Karma
Those people have manyastambha at least for 3 months
Radiograph scoring system of cervical spondylosis will be confirmed by x ray |
|
| ExclusionCriteria |
| Details |
Pregnant women and lactating mothers
Known patients of carcinoma of TB of Spine patients with rheumatoid arthritis gout and any other major illness
Patients having fractures and dislocation of bone
Below 18 and above 60 yrs male and female
Patients unfit for Nasya Karma |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
effect of Suddha Bala Taila Nasya in the
management of Manyastambha
|
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Nil
|
Nil |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
28/03/2025 |
| 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 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
|
This study is a observational study to evaluate the efficacy of suddha bala taila nasya in the management of manyastambha Study will be carried in OPD of Panchakarma department of Late Kedari Redekar Ayurvedic Mahavidyalaya and Hospital Gadhinglaj The observation would be drawn on the basis of symptoms after treatment given |