| CTRI Number |
CTRI/2024/11/076591 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
07/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Yoga and Medicine on lower back pian |
|
Scientific Title of Study
|
Effect of Yogic Practices and Medication in Sciatica |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hare Ram Pandey |
| Designation |
Ph.D. scholar |
| Affiliation |
Departament of Yoga, Indira Gandhi National Tribal University |
| Address |
Departament of Yoga, Indira Gandhi National Tribal University,
Amarkantak Distt- Anuppur- 484887 (M.P)
Shahdol
MADHYA PRADESH
484887
India |
| Phone |
9415033244 |
| Fax |
|
| Email |
hrpandey@igntu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Hare Ram Pandey |
| Designation |
Ph.D. scholar |
| Affiliation |
Departament of Yoga, Indira Gandhi National Tribal University |
| Address |
Departament of Yoga, Indira Gandhi National Tribal University,
Amarkantak Distt- Anuppur- 484887 (M.P)
Shahdol
MADHYA PRADESH
484887
India |
| Phone |
9415033244 |
| Fax |
|
| Email |
hrpandey@igntu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Hare Ram Pandey |
| Designation |
Ph.D. scholar |
| Affiliation |
Departament of Yoga, Indira Gandhi National Tribal University |
| Address |
Departament of Yoga, Indira Gandhi National Tribal University,
Amarkantak Distt- Anuppur- 484887 (M.P)
Shahdol
MADHYA PRADESH
484887
India |
| Phone |
9415033244 |
| Fax |
|
| Email |
hrpandey@igntu.ac.in |
|
|
Source of Monetary or Material Support
|
| Bjain Pharmaceuticals Pvt. Ltd. A-98, Sector-63, Noida-201307 |
|
|
Primary Sponsor
|
| Name |
Department of Yoga Indira Gandhi National Tribal University Amarkantak MP |
| Address |
Amarkantak, M.P |
| Type of Sponsor |
Other [Central University(HEI)] |
|
|
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 Hare Ram Pandey |
Sir Sunder Lal Hospital, Ayurvedic wing, IMS, BHU Varanas |
C/O Dr. Mamta Tiwari,OPD Room no- 13 D, Deaprtment of Swathvritt and Yoga,Ayurvedic wing, Sir Sunder Lal Hospital
I.M.S, B.H.U, Varanasi
UTTAR PRADESH
Varanasi
UTTAR PRADESH |
9415033244
hrpandey@igntu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IGNTU-IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homeopathy Medicine |
Homeopathy medicine-
The composition of the Homeopathy medicine is - Aconitum napellus 3X (20% v/v), Arsenicum album 6X (20% v/v), Colocynthis 3X (20% v/v), Gnaphalium polycephalum 3X (20% v/v), Magnesium phosphoricum 3X (10% w/v), Excipients q.s., Alcohol content (72% v/v).
Dosage: 10-15 drops three times a day.
|
| Comparator Agent |
Standard treatment of Sciatica |
Allopathy and other therapies for Sciatica |
| Intervention |
Yoga practice
|
Yoga practice -
Prayer,
sukshma vyayam -
1. Padanguli Naman
2. Goolf Naman
3. Goolf Chakra
4. Janu Naman
5. Mushtika Bandhan
6. Manibandh Naman
7. Manibandh Chakra
8. Griva Sanchalan
9. Skandha Chakra
Asana -
1. Supta Tadasana
2. Makarasana
3. Saral Bhujangasana
4. Ardh Shalabhasana
5. Sarpasana
6. Shavasana
Pranayama-
1. Nadi Shodhana
2. Bhramari
Om chanting,
Shanti paath. |
| Intervention |
Yoga practice with Homeopathy medicine |
Yoga practice -
Prayer,
sukshma vyayam -
1. Padanguli Naman
2. Goolf Naman
3. Goolf Chakra
4. Janu Naman
5. Mushtika Bandhan
6. Manibandh Naman
7. Manibandh Chakra
8. Griva Sanchalan
9. Skandha Chakra
Asana -
1. Supta Tadasana
2. Makarasana
3. Saral Bhujangasana
4. Ardh Shalabhasana
5. Sarpasana
6. Shavasana
Pranayama-
1. Nadi Shodhana
2. Bhramari
Om chanting,
Shanti paath.
Homeopathy medicine-
The composition of the Homeopathy medicine is - Aconitum napellus 3X (20% v/v), Arsenicum album 6X (20% v/v), Colocynthis 3X (20% v/v), Gnaphalium polycephalum 3X (20% v/v), Magnesium phosphoricum 3X (10% w/v), Excipients q.s., Alcohol content (72% v/v).
Dosage: 10-15 drops three times a day.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Both |
| Details |
Individuals aged between 18 and 64 years.
ii) Participants persistently suffering from lower back pain for more than 12 weeks.
iii) Participants seeking medical attention for mild sciatic symptoms during their
initial visit to the doctor.
iv) Participants having mean pain intensity of more than 4 on numerical rating scale.
v) Male and female individuals meeting the age and symptom criteria will be
approached for potential participation.
vi) Only individuals who provide informed consent will be considered for inclusion
in the study.
vii) Prospective participants expressing a willingness to adhere to the prescribed
yogic practices and medication regimen throughout the study duration.
viii) Patient with no prior experience of yoga |
|
| ExclusionCriteria |
| Details |
i.
Patients currently undergoing any form of therapeutic treatment for their
sciatic symptoms will be excluded.
ii.
Individuals aged 65 years and above will not be included in the study.
iii.
Individuals with unstable medical conditions, such as uncontrolled
hypertension, uncontrolled diabetes mellitus or cardiovascular disorders, will
be excluded to ensure participant safety.
iv.
Individuals who have participated in a similar study assessing the effects of
yoga on sciatic symptoms in the last six months will be excluded.
v.
Pregnant women will be excluded from the study.
vi.
Individuals with a back surgery in last 3 years will be excluded.
vii.
Patients suffering from spinal canal stenosis, spondylolisthesis, severe
progressive neurological disorders.
viii.
Patients suffering from serious psychiatric co-morbidities.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Single Leg Raise (S.L.R.) test, Visual Analogue Scale
(V.A.S.), Oswestry Disability Index (ODI)
|
30 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life |
30 day |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
18/11/2024 |
| 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="3"
Months="0"
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
|
The Effect of Yogic Practices and Medication in Sciatica to address lower backache involves considering both traditional wisdom and scientific evidence. We are taking a sample size of 180 patients and it will be distributed in 4 arms study of 45 patients simultaneously. Results will be helpful for further alternative therapy and its effects on the modern world. |