| CTRI Number |
CTRI/2022/05/042388 [Registered on: 05/05/2022] Trial Registered Prospectively |
| Last Modified On: |
19/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Add on effect of Nasya Karma with Interferential Therapy in the management of Manyastambha (Cervical Spondylosis) |
|
Scientific Title of Study
|
Assessment of add on effect of Nasya Karma with Interferential Therapy in the management of Manyastambha (Cervical Spondylosis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Upasana Narania |
| Designation |
PG Scholar |
| Affiliation |
Bharati Vidyapeeth Deemed to be University, College of Ayurved and hospital, Pune.43 |
| Address |
Department of Panchakarma
Bharati Vidyapeeth (Deemed to be University)College of Ayurveda and Hospital Dhanakawadi
Pune-411043
Maharashtra
India
Pune
MAHARASHTRA
411043
India |
| Phone |
7006055153 |
| Fax |
2024321910 |
| Email |
upasananarania@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjula Chavan Matekar |
| Designation |
Associate Professor |
| Affiliation |
Bharati Vidyapeeth Deemed to be University, College of Ayurved and hospital, Pune.43 |
| Address |
Department of Panchakarma
Bharati Vidyapeeth (Deemed to be University)College of Ayurveda and Hospital Dhanakawadi
Pune-411043
Maharashtra
India
Pune
MAHARASHTRA
411043
India |
| Phone |
9890254424 |
| Fax |
2024321910 |
| Email |
manjulamatekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Upasana Narania |
| Designation |
PG Scholar |
| Affiliation |
Bharati Vidyapeeth Deemed to be University, College of Ayurved and hospital, Pune.43 |
| Address |
Department of Panchakarma
Bharati Vidyapeeth (Deemed to be University)College of Ayurveda and Hospital Dhanakawadi
Pune-411043
Maharashtra
India
Pune
MAHARASHTRA
411043
India |
| Phone |
7006055153 |
| Fax |
2024321910 |
| Email |
upasananarania@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth (Deemed to be University) College of Ayurved Pune-411043 |
|
|
Primary Sponsor
|
| Name |
Dr Upasana Narania |
| Address |
Bharati Vidyapeeth (Deemed to be University)College of Ayurveda and Hospital Dhanakawadi
Pune-411043
Maharashtra
India |
| Type of Sponsor |
Other [(Self)] |
|
|
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 Upasana Narania |
Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital Pune |
Panchakarma OPD Ground Floor,
College of Ayurveda and Hospital Dhanakawadi
Pune-411043
Maharashtra
India
Pune
MAHARASHTRA |
7006055153
2024321910
upasananarania@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BV(DU)COA Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M479||Spondylosis, unspecified. Ayurveda Condition: MANYASTAMBAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Ayurvedic Panchakarma Vigyan by Shreedhar Kasture and Clayton’s Electrotherapy, Procedure details: Nasya- Gudadi nasya 8 drops (0.05ml) to be administered in each nostril after sthanik snehana and swedana once everyday for 7 days between 11am to 5pm and Interferential Therapy- It is a form of electrical treatment in which two medium frequency currents (one of 4000Hz and other at a varying frequency i.e. less than the first one) are used to produce a low frequency effect (the difference of the two also known as beat frequency) which is applied on the affected part. Out of four electrodes two a)
(1) Medicine Name: Gudadi Nasya, Reference: Shadangdhar Samhita Chapter 8 Nasya Vidhi, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 8(drops), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Interferential Therapy | Interferential Therapy- It is a form of electrical treatment in which two medium frequency currents (one of 4000Hz and other at a varying frequency i.e. less than the first one) are used to produce a low frequency effect (the difference of the two also known as beat frequency) which is applied on the affected part. Out of four electrodes two are placed at Para-spinal muscles and the other two are placed at sub-scapular space/over the trapezius muscle b/l).
This is to be done once daily for 20 m |
|
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Selection of the patients will be done irrespective of sex, socio-economic status
2.Patients of age group between 20 to 60 years
3.Patients with written consent
4. Patients who are indicated for Nasya and Interferential Therapy
5.Patients having symptoms of Manyastambha i.e. pain, stiffness, immobility in the back of the neck |
|
| ExclusionCriteria |
| Details |
1.Patients below 20 years and above 60 years will be excluded.
2.Pregnant women and lactating mothers will be excluded
3.Patients continuing any other medication for Manyastambha
4.Patients contraindicated for Nasya and Interferential Therapy
5.Patients who are intolerant to heat will be excluded
6. Patients suffering/under medication for any other serious illness(Patients with pacemakers,Diabetes,Hypertension,Heart Diseases, Radiculopathy,Any shoulder pathology) |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in symptoms of Manyastambha i.e. pain, stiffness, rigidity, immobility in back of the neck |
7th day, 15th day, 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in movements of the neck |
7th day, 15th day, 30th day |
|
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Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
05/05/2022 |
| Date of Study Completion (India) |
20/02/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Patients suffering from Manyastambha ( Cervical Spondylosis) between the age group of 20-60 years and who fit the inclusion criteria were randomly selected and divided into two groups having 20 patients each.Group A received Nasya and Interferential Therapy for a period of 7 days, Group B was given Interferential Therapy for a period of 7 days. Patients were assessed for reduction in the symptoms of Manyastambha and assessed for improvement on 7th day, 15th day, and 30th day. The study showed significant improvement in symptoms and better and lasting results in Group-A than Group -B.
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