| CTRI Number |
CTRI/2024/08/072410 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
09/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
In study of patients of Manyastambha(neck pain and stiffness) one group will be treated with Masha Pinda sweda and one group will be treated with Masha Pradeha for 7 days |
|
Scientific Title of Study
|
Comparative clinical study of Masha pinda sweda and Masha pradeha in 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. Ankita Vijaysa Nilkanth |
| Designation |
M.d. Scholar Panchkarma |
| Affiliation |
Sumatibhai Shah ayurveda mahavidyalay pune |
| Address |
Sumatibhai shah Ayurveda Mahavidyalaya
OPD No.6,Department of Panchkarma,Sane Guruji Arogya Kendra,Hadpsar,Malawadi,Pune 411028 Maharashtra India
Pune
MAHARASHTRA
411028
India |
| Phone |
8149723528 |
| Fax |
|
| Email |
nilkanthankita4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Maya Gokhale |
| Designation |
Head of department of Panchakarma |
| Affiliation |
Sumatibhai Shah ayurveda mahavidyalay pune |
| Address |
Sumatibhai shah Ayurveda Mahavidyalaya
OPD No.6 Department of Panchkarma, Sane Guruji Arogya Kendra,Hadpsar,Malawadi,Pune 411028 Maharashtra India
Pune
MAHARASHTRA
411028
India |
| Phone |
9422323285 |
| Fax |
|
| Email |
drmayagokhale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ankita Vijaysa Nilkanth |
| Designation |
M.d. Scholar Panchkarma |
| Affiliation |
Sumatibhai Shah ayurveda mahavidyalay Pune |
| Address |
Sumatibhai shah Ayurveda Mahavidyalaya,OPD No. 6 Department of Panchkarma, Sane Guruji Arogya Kendra Malawadi Hadpsar Pune 411028 Maharashtra, India
Pune
MAHARASHTRA
411028
India |
| Phone |
8149723528 |
| Fax |
|
| Email |
nilkanthankita4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Panchakarma, Sane Guruji Arogya kendra Malawadi Hadpsar Pune 411028 |
|
|
Primary Sponsor
|
| Name |
Sane Guruji Arogya kendra |
| Address |
Sane Guruji Arogya kendra, Malawadi Hadpsar Pune 411028 Maharashtra India |
| 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 Ankita Vijaysa Nilkanth |
Sane Guruji Arogya kendra |
OPD No.6,Department of Panchkarma,Malawadi,Hadpsar Pune 411028
Pune
MAHARASHTRA |
8149723528
nilkanthankita4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| M.A.M.s SSAM and Sane Guruji Arogya Kendra Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M488||Other specified spondylopathies. Ayurveda Condition: MANYASTAMBAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | piNDasvedaH, पिणà¥à¤¡à¤¸à¥à¤µà¥‡à¤¦à¤ƒ | (Procedure Reference: Kale V; Charak Samhita by Aacharya Charak; Vol-I, Chaukhamba Prakashan, Delhi, Edition-2016; Sutrasthan 14/41 pg.no.231, Procedure details: Application of heated bolus of Masha to inducing Sweda for 20 minutes is known as Pinda Sweda.It is done for once a day for 7 days)
(1) Medicine Name: Masha, Reference: The Ayurvedic Pharmacopia of India, Part 1, Volume 3, Masha, pg no-118, Goverment of India, Ministry of Health and Family welfare, Department of AYUSH., Route: Topical, Dosage Form: Kalka/ Paste, Dose: 50(mg), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | pradeha, पà¥à¤°à¤¦à¥‡à¤¹ | (Procedure Reference: Yadavsharmana P; Sushruta Samhita by Acharya Sushruta; Chaukhamba Sanskrit Sansthan, Varanasi, Chikitsa Sthana, 32/12 pg.no.513., Procedure details: Grinded & heated paste of Masha is applied on body part to inducing the Sweda for 20 minutes. It is done once a day for 7 days )
(1) Medicine Name: Masha, Reference: The Ayurvedic Pharmacopia of India, Part 1, Volume 3, Masha, pg no-118, Goverment of India, Ministry of Health and Family welfare, Department of AYUSH., Route: Topical, Dosage Form: Kalka/ Paste, Dose: 50(g), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having classical symptoms of Manyastambha.
Gender- Male and Female.
Age Group- 30-60 yrs
Snehan arha
Swedana arha
Patients having restricted range of movement of neck |
|
| ExclusionCriteria |
| Details |
Any systemic disease which may cause interference in the treatment.
Cervical vertebrae fracture.
Any other structural deformities of cervical spine. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Compare the effect of Masha Pinda sweda and Masha Pradeha in Manyastambha |
Treatment will be given for 7 days.Patients will be assessed on 0 th, 7 th day and follow up on 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the effect in neck pain & stiffness after the procedure of Masha Pinda sweda in Manyastambha
To assess the effect in neck pain & stiffness after the procedure of Masha Pradeha in Manyastambha |
Patients will be assessed on 0 th,7th day & follow up on 15th day
Patients will be assessed on 0 th,7th day & follow up on 15th day |
|
|
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)
|
20/08/2024 |
| 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="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
|
This is a Comparative clinical study of two different types of Swedana that is Masha Pinda sweda and Masha Pradeha in Manyastambha. The primary objective is to compare the effect of two different types of Swedana.One group of Manyastambha patients will be treated with Masha Pinda sweda for 7 days. Second group of Manyastambha patients will be treated with Masha Pradeha for 7 days. Observation will be drawn from the outcome of treatment. |