| CTRI Number |
CTRI/2025/04/084607 [Registered on: 11/04/2025] Trial Registered Prospectively |
| Last Modified On: |
09/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [YOGA ASANA] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to assess the effect of Bhujangasana with Shalabhasana and Bhujanasana with Makarasana in Low back pain.
|
|
Scientific Title of Study
|
A comparative clinical study to assess the effect of Bhujangasana with Shalabhasana and Bhujangasana with Makarasana in katishool w.s.r. to Low back pain.
|
| 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 Ritu Raisinghani |
| Designation |
PG Scholar Department of Swasthavritta Evam Yoga |
| Affiliation |
Rani dullaiya smriti ayurved P.G. mahavidyalaya evam chikitsalaya, barkhedi-kalan, bhadabhada road, bhopal, (M.P.) |
| Address |
Department of Swasthvritta Evam Yoga, O.p.d No. 2,Rani dullaiya smriti ayurved P.G. mahavidyalaya evam chikitsalaya, barkhedi-kalan, bhadabhada road, bhopal, (M.P.)
Bhopal
Madhya Pradesh
462044
India
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
7693824031 |
| Fax |
|
| Email |
rituraisinghani18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamata P. Tirankar |
| Designation |
Associate professor department of swasthvritta evam yoga |
| Affiliation |
Rani dullaiya smriti ayurved P.G. mahavidyalaya evam chikitsalaya, barkhedi-kalan, bhadabhada road, bhopal, (M.P.) |
| Address |
Department of Swasthvritta Evam Yoga, O.p.d No. 2,Rani dullaiya smriti ayurved P.G. mahavidyalaya evam chikitsalaya, barkhedi-kalan, bhadabhada road, bhopal, (M.P.)
Bhopal
Madhya Pradesh
462044
India
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
8643015825 |
| Fax |
|
| Email |
tirankarmamata@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mamata P. Tirankar |
| Designation |
Associate professor department of swasthvritta evam yoga |
| Affiliation |
Rani dullaiya smriti ayurved P.G. mahavidyalaya evam chikitsalaya, barkhedi-kalan, bhadabhada road, bhopal, (M.P.) |
| Address |
Department of Swasthvritta Evam Yoga, O.p.d No. 2,Rani dullaiya smriti ayurved P.G. mahavidyalaya evam chikitsalaya, barkhedi-kalan, bhadabhada road, bhopal, (M.P.)
Bhopal
Madhya Pradesh
462044
India
Bhopal
MADHYA PRADESH
462044
India |
| Phone |
8643015825 |
| Fax |
|
| Email |
tirankarmamata@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rani dullaiya smriti ayurved P.G. mahavidyalaya evam chikitsalaya, barkhedi-kalan, bhadabhada road, bhopal, (M.P.) |
|
|
Primary Sponsor
|
| Name |
Dr Ritu Raisinghani |
| Address |
PG scholar, Rani dullaiya smriti ayurved P.G. mahavidyalaya evam chikitsalaya, barkhedi-kalan, bhadabhada road, bhopal, (M.P.) |
| 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 Ritu Raisinghani |
Rani Dullaiya Smriti Ayurved Hospital Bhopal |
P.G. Department Of Swasthavritta Evam Yoga, Opd No. 2, Rani Dullaiya Smriti Ayurved PG Evam Chikitsalaya,Barkhedi Kalan,Bhopal M.P.
Bhopal
Madhya Pradesh
462044
Bhopal
MADHYA PRADESH |
7693824031
rituraisinghani18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Comittee , Rani Dullaiya Smriti Ayurved PG Evam Chikitsalaya,Barkhedi Kalan,Bhopal M.P. |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M628||Other specified disorders of muscle. Ayurveda Condition: SAMANAVATAKOPAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Gherand Samhita,Commentary on yoga teachings of Maharishi Gherand, Swami Niranjannanda Saraswati, Yoga Publication Trust Munger, Bihar India, Pg- 265-267 and 260-261
Yoga asana:Bhujangasana with Makarasana
Duration:35 days
Information: Bhujangasana with Makarasana is effective for people suffering from lower back pain. This encourages the vertebral column., Pathya/Apathya:no, Pathya:, Apathya: | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Gherand Samhita,Commentary on yoga teachings of Maharishi Gherand, Swami Niranjannanda Saraswati, Yoga Publication Trust Munger, Bihar India, Pg- 265-267 and 256-259
Yoga asana:Bhujangasana with Shalabhasana
Duration:35 days
Information: Bhujangasana with Shalabhasana helps to remove backache and keep the spine supple and healthy., Pathya/Apathya:no, Pathya:, Apathya: |
|
|
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Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with classical signs and symptoms – Pain, Stiffness, Tenderness, Heaviness or restricted movements. |
|
| ExclusionCriteria |
| Details |
1.Handicapped Patients.
2. Cases with low back pain as accident and other spinal injuries.
3. Cases with history of severe orthopaedic condition as Lumbar spondylitis etc.
4. Pregnancy and Lactating mothers.
5. Congenital Deformities.
6. Any Diagnosed Pathology.
|
|
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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 |
| Reduce pain and stiffness of the lower back pain |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Reduce the pain radiation & stiffness & tenderness of lower back
2.Marked improvement
|
35 DAYS |
|
|
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)
|
28/04/2025 |
| 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="2"
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 prevalence of LBP in Indian population has been found to vary between 6.2% (in general population) to 92% (in construction workers). At any given time, 2.4 million of the world population are disabled because of low back pain, with 1.2 million on a chronic basis. Asana, being the first accessory of Hatha Yoga, âsana is described first. It should be practised for gaining steady posture, health and lightness of body. & also in Gherand Samhita, through Asanas, firmness is achieved.) During asana practice the habit of taking slow, deep breaths is developed, which in turn helps the practitioner to achieve mental and emotional balance. Thus, previous research work shows the study of effect of single asana and now my present work will be on the combined effect on each group will be noted as Bhujangasana with Shalabhasana and Bhujangasana with Makarasana. As mentioned in Gherand Samhita, Bhujangasana, Shalabhasana, Makarasana works effectively in low back pain. ) |