| CTRI Number |
CTRI/2024/11/077348 [Registered on: 26/11/2024] Trial Registered Prospectively |
| Last Modified On: |
14/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study on Manyagraha disease with Ashtchatvarinshat Guggul Gutika orally and Shasht Mahamash Tailam Nasya |
|
Scientific Title of Study
|
Randomized open controlled clinical study to evaluate the efficacy of ‘Ashtchatvarinshat Guggul Gutika orally and ‘Shasht Mahamash Tailam for Nasya in the management of Manyagraha w.s.r. to Cervical Spondylosis in the age group of 30 to 70 years |
| 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 Siddheshwar Shivaji Shrirang |
| Designation |
PG Scholar |
| Affiliation |
Dayabhai Maoji Majithiya Ayurved Mahavidyalay and L.K. Ayurved Rugnalaya Yavatmal |
| Address |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with L.K. Ayurved Rugnalaya, Department of Kayachikitsa, Ground floor OPD No.10, Yavatmal
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
9657141595 |
| Fax |
|
| Email |
shrirangsiddheshwar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suryaprakash K Jaiswal |
| Designation |
Professor, PG and PhD guide |
| Affiliation |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with L.K. Ayurved Rugnalaya, Yavatmal |
| Address |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with L.K. Ayurved Rugnalaya, Department of Kayachikitsa, Ground floor OPD No.10, Yavatmal
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
9822126706 |
| Fax |
|
| Email |
dr.skjaiswal01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Siddheshwar Shivaji Shrirang |
| Designation |
PG Scholar |
| Affiliation |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with L.K. Ayurved Rugnalaya, Yavatmal |
| Address |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with L.K. Ayurved Rugnalaya, Department of Kayachikitsa, Ground floor OPD No.10, Yavatmal
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
9657141595 |
| Fax |
|
| Email |
shrirangsiddheshwar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with L.K. Ayurved Rugnalaya, Shivaji nagar, Arni road, Yavatmal, 445001 |
|
|
Primary Sponsor
|
| Name |
DMM Ayurved Mahavidyalaya Yavatmal |
| Address |
Dayabhai Maoji Majithiya affiliated with L.K. Ayurved Rugnalaya, Department of Kayachikitsa, Ground floor OPD No.10,Shivaji Nagar, Yavatmal,Arni road Dist.Yavatmal 445001 |
| Type of Sponsor |
Other [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 Siddheshwar Shivaji Shrirang |
Dayabhai Maoji Majithiya Ayurved Mahavidhyalaya and L. K. Ayurved Rugnalaya, Yavatmal |
OPD NO. 10, Department of kayachikitsa,Shivaji nagar, Arni road, Yavatmal, 445001
Yavatmal
MAHARASHTRA |
9657141595
shrirangsiddheshwar@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee, DMM Ayurved Mahavidyalaya, Yavatmal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M479||Spondylosis, unspecified. Ayurveda Condition: MANYASTAMBAHÂ (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ashtchatvarinshat Guggul Gutika, Reference: Gadnigraha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Koshanjala ), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shasht Mahamash Tailam , Reference: Chakradatt, Route: Nasal, Dosage Form: Taila, Dose: 4(drops), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Trayodashang Guggul Gutika, Reference: Bhaishajya Ratnawali , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Koshanjala ), Additional Information: - | | 4 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Sahachar Tailam, Reference: Gadnigraha, Route: Nasal, Dosage Form: Taila, Dose: 4(drops), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Age group 30 - 70 years irrespective of caste, any gender, religion, socio-economic and educational status. 2) Radiological degenerative changes in Cervical spines 3) Patient having sign (Hyper Reflexia, Sensory Loss) and symptoms (Ruja, Neck pain, Vertigo ,Headache,Neck stiffness) of Manyagraha according to classics. 4) Patient willing and able to participate in the study. 5) Cervical (Neck) pain. |
|
| ExclusionCriteria |
| Details |
1) History of any fracture of vertebral joints / surgical /diagnostic intervention with reference to affected joints will be excluded. 2) Gross disability in performing daily normal routine i.e. bedridden patient or confined to a wheelchair will be excluded. 3) Patient with co-morbidities such as rheumatoid arthritis, psoriatic arthritis,slip disc and Potts Spine. 4) Patient with any deformity of cervical or back altering the gait and posture of the patient. 5) Severe alcoholic patient. 6) Age group below 30 yrs and above 70 yrs. 7) Spinal stenosis (narrowing of the spinal canal), vertebral instability. |
|
|
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
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The parameters will be noted down before and after treatment. 1.Manyaruja (Neck pain) 2.Manyasthambha (Neck stiffness) 3.Bhrama (Vertigo) 4.Shiroruja (Headache) 5.Tingling sensation in the upper limb. |
0,7th,15th,23nd,30th,38th,45th,60th75th,90th |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.VAS Scale
2.Neck Disability Index(NDI) |
0,7th,15th,22nd,30th,38th,45th,60th,75th,90th |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
10/01/2025 |
| 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
|
Now a day’s due to occupational stress,poor posture in sitting or sleeping, excessive travelling etc.leads to spondylotic changes in cervical spine. Cervical spondylosis is a clinical condition in which structural Dearrangement of cervical region has taken place due to which the movement of neck restricted and space is diminished. Manyagraha can be compared with cervical spondylosis in ayurvedic text which is painful disorder mainly associated with vitiation of Vata and vyan vayu. The aggrevated Vata in Manya Sanshrit Nadi leads to the symptoms of ruja(Pain),Sthambha(Restricted movement),etc. |