Ayurvedic Management of Manyagraha (cervical spondylosis)
- Conditions
- Nerve root and plexus compressionsin diseases classified elsewhere. Ayurveda Condition: Manyagraha,
- Registration Number
- CTRI/2022/05/042679
- Lead Sponsor
- Self Pranali Ashok Waykar
- Brief Summary
**Plan of Work:**
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|After Institutional Ethics Clearance of Government Ayurved College, Nagpur screening of population will be done from patients in OPD, IPD and casualty of our institute. In the clinical study 76 patients of Manyagraha will be included. If patient fulfill the criteria of inclusion, subject would also be given freedom to ask the questionsand all questions will be answered. If he/she agrees for participation in the study and found fit to include, the patient will be included in the study.
The treatment will be given to patient as follows:
1. Nasya with Anu Tail (21 days)
2. Vatanashak Ghanavati (21 days)
In study assessment on Oswestry Neck Disability Score and symptoms of Manyagraha will be taken on zero day (B.T. Assessment) and on 22ndday after completion of 21 days of course of treatment. (A.T Assessment).
**Medium of Dissertation****:**The study will be written in English and Sanskrit words will be used where ever necessary.
**Type of study**: Open Label Parallel Superiority Randomized Controlled Trial
**Duration of Treatment:**21 days.
**Ethical Clearance:**Clearance from Institutional Ethics Committee.
**Study setting:** OPD, IPD and casualty of our institute.
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|**Duration of**
**study:**Study will be carried out for 18 months after approval of synopsis.
**Study Population :**
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|1. All the patients attending OPD, IPD and casualty of our institute will be considered in this study.
2. Patient will be diagnosed on the basis of Oswestry Neck Disability Questionnaire, Radiological changes, i.e, degenerative changes in cervical vertebrae will also be considered.
3. Patient with signs and symptoms of *Manyagraha* will also be the criteria for selection of patient.
**Sample size:**
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|Sample size was calculated with the help of Data published by Solanke S. et all (2021) entitled as “Randomized Control Trial On *Erandmula Ghanavati* With *Nasya* In *Manyagraha* With Special Reference To Cervical Spondylosis.†In his Data The Main Criteria of assessment of Oswestry Neck Disability Questionnaire was considered. He had treated the patients of *Manyagraha* w.s.r to Cervical Spondylosis by *Erandmula Ghanavati* along with *Nasya*.
The mean of Oswestry Neck Disability Score before starting treatment was 20.32 + 2.70 (considering 10% of the difference from Mean of Oswestry Neck Disability Index i.e. 2.032 of treated Group which is 18.29). The sample data was placed in Open epi sample size calculator software and the sample size was calculated. It was 29.
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|1. Further making it a round figure sample size is taken as 30. By considering the 10% dropout and 10% unresponsive. Therefore sample size is 38. Thus patients in Group A are 38, patients in Group B are 38. **Total Sample=76**
2. Considering the incidence in OPD data of Kayachikitsa department and present situation, patients randomly suffering from *Manyagraha,* fulfilling criteria of diagnosis will be registered, among these 76 will be studied in this series from the population.
3. Out of 76 patients 38 patients in each of **Trial** and **Control Groups** will be included.
4. Therefore 76 patients will be selected to be studied in this series by Random Generator Software.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 76
- 1.Patients having signs and symptoms of Manyagraha according to classics.
- 2.Radiological changes i.e., degenerative changes in cervical vertebrae.
- 3.The Oswestry neck disability questionnaire, which has been described in criteria of assessment will be taken into account where score ≥ 10 will be included.
- 4.Patient with age group 30-70 yrs irrespective of sex, occupation, socio-economic status.
- 5.Patient willing and able to participate in the study and agrees to fill the consent form.
- 6.Patients not willing for trial.
- History of any fracture of vertebral joint/ surgical/ diagnostic intervention with reference to affected joints will be excluded.
- 1.The patient who had fix joint or having developed contracture not be included in study.
- 2.Patient who are not fit for Nasya.
- 3.Patient with uncontrolled hypertension and uncontrolled diabetes will be ruled out.
- 4.Patient who have serious and complicated systemic disorders will be excluded.
- 5.Patient with evidence of malignancy.
- 6.Patient on prolonged (≥6weeks) medication with corticosteroids, non steroidal anti- inflammatory drug, antidepressants, anti cholinergic etc.
- or any drugs that may influence on the outcome of the study.
- 7.Pregnant / lactating women.
- 8.Patients who had participated in any other clinical trial since last six months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Oral administration of Vatanashak Ghanavati with Anu Tail Nasya is more effective as Erandamula Ghanavati with Anu Tail Nasya in patients of Manyagraha with reference to cervical spondylosis specifically on Oswestry Neck Disability Index. 3 weeks
- Secondary Outcome Measures
Name Time Method Oral administration of Vatanashak Ghanavati with Anu Tail Nasya is more effective than Erandamula Ghanavati with Anu Tail Nasya in patients of Manyagraha with reference to cervical spondylosis specifically on Oswestry Neck Disability Index. 21 days
Trial Locations
- Locations (1)
Government Ayurveda College And Hospital, Nagpur
🇮🇳Nagpur, MAHARASHTRA, India
Government Ayurveda College And Hospital, Nagpur🇮🇳Nagpur, MAHARASHTRA, IndiaPranali Ashok WaykarPrincipal investigator7057359491pranali22waykar@gmail.com