| CTRI Number |
CTRI/2024/05/067945 [Registered on: 27/05/2024] Trial Registered Prospectively |
| Last Modified On: |
21/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Musculoskeletal Pain Management By Oil Enema In Perimenopausal And Postmenopausal Woman. |
|
Scientific Title of Study
|
A Randomized Clinical Study On Efficacy Of Anuvasna Basti With Special Reference To Musculoskeletal Pain In Premenopausal Postmenopausal Phase |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Richa Dwivedi |
| Designation |
MD scholar |
| Affiliation |
National Institute Of Ayurveda |
| Address |
Room no. 113 A,Panchkarma Department, National Institute Of Ayurveda,Jorawar singh gate,Amer road,Jaipur.
Madhav Vilas Palace,Joravar singh gate,Amer road,Jaipur.
Jaipur
RAJASTHAN
302002
India |
| Phone |
8107825118 |
| Fax |
|
| Email |
richadwivedi4545@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kshipra Rajoria |
| Designation |
Senior Assistant Professor |
| Affiliation |
National Institute Of Ayurveda |
| Address |
Room no. 113 A,Panchkarma Department, National Institute Of Ayurveda,Joravar singh gate,Amer road,Jaipur.
Madhav Vilas Palace,Joravar singh gate,Amer road,Jaipur.
Jaipur
RAJASTHAN
302002
India |
| Phone |
9001454100 |
| Fax |
|
| Email |
kshiprarajoria@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kshipra Rajoria |
| Designation |
Senior Assistant Professor |
| Affiliation |
National Institute Of Ayurveda |
| Address |
Room no. 113 A,Panchkarma Department, National Institute Of Ayurveda,Joravar singh gate,Amer road,Jaipur.
Madhav Vilas Palace,Joravar singh gate,Amer road,Jaipur.
Jaipur
RAJASTHAN
302002
India |
| Phone |
9001454100 |
| Fax |
|
| Email |
kshiprarajoria@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Ayurveda,Joravar Singh Gate,Amer Road,Jaipur,302002,Rajasthan,India. |
|
|
Primary Sponsor
|
| Name |
National Institute Of Ayurveda |
| Address |
Madhav Vilas Palace,Joravar Singh Gate,Amer Road,Jaipur,302002,Rajasthan
India. |
| Type of Sponsor |
Government medical college |
|
|
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 |
| DrKshipra Rajoria |
National Institute Of Ayurveda |
O.P.D. No.-2,Panchkarma Department,Madhav Vilas Palace,Joravar Singh Gate,Amer Road,Jaipur,302002,Rajasthan,
India.
Jaipur
RAJASTHAN |
9001454100
kshiprarajoria@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee National institute of ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R299||Unspecified symptoms and signs involving the nervous and musculoskeletal systems. Ayurveda Condition: SARVANGAVATAH/SARVANGAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | anuvAsana-bastiH, अनà¥à¤µà¤¾à¤¸à¤¨-बसà¥à¤¤à¤¿à¤ƒ Pradhan Karma | (Procedure Reference: charaka samhita siddhi sthana 1/29-34, Procedure details: BASTI KARMA (Anuvasna-mashadi taila Basti)
Snehana-Dashmool taila (Sarvang snehan for 30-45 min.)
Swedana- Vashpa Swed (3-5 min.)
Anuvasnaa Basti-Anuvasna Basti with Mashadi Taila after lunch.
The total number of Basti administered will be 15 on daily basis.
Dosage - ~ 72 ml
Follow – up – on 30th day from baseline in each arm. )
| | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:COMMON YOGA PROTOCOL
Common yoga protocol includes asana, pranayama, and meditation given by Ministry of Ayush Government of India, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1.Female with classical sign and symptoms of Sarvangavata.
2.Females in perimenopausal/postmenopausal phase.
3.Patient willing and able to participate in this study for entire trial period with informed consent.
4.Patient fit for Anuvasna Basti karm.
5.Patients with a washout period of 15 days, who have been taking medication or panchakarma therapy for same condition.
6.Females between the age of 35 to 65 years. |
|
| ExclusionCriteria |
| Details |
XCLUSION CRITERIA
1.Patient, suffering from any acute or chronic debilitating disease (conditions involving cardiac, vascular, hematological, respiratory, hepatic, gastrointestinal, renal functions, endocrinal, central nervous system. or psychiatric disorder or active cancer) and having other serious pathology.
2.Patients with long term steroid treatment. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Numerical Rating Scale (NRS) for pain |
30th day from baseline in each arm. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in EuroQol-5-Dimension. |
30th day from baseline in each arm. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Pain is described as "an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage" by the International Association for the Study of Pain (IASP). Acute or persistent pain that affects the bones, muscles, ligaments, tendons, and even nerves is referred to as musculoskeletal pain (MSP), and it is a widespread medical and socioeconomic issue across the world. Joint and musculoskeletal problems can cause pain, which is a significant symptom that can lead to function loss. As a result, it may be employed as a prognostic and/or therapeutic indication of the illness state and is indicative of the severity and activity of the underlying medical condition. Musculoskeletal pain is prevalent and places a significant strain on individuals as well as social and healthcare institutions, impacting both sexes, people of all ages, and people from all socioeconomic backgrounds. Musculoskeletal pain is becoming more common, and it has been called an epidemic. According to the World Health Organization (WHO), 20–33% of the world’s population has some form of chronic musculoskeletal pain, translating to 1.75 billion people globally. Perimenopause is a state during which women are particularly predisposed to develop MSP. As to moderate to severe degrees of MSP, the odds increase linearly with age, from pre-menopause to peri- and then to post-menopause. The estimated overall prevalence of MSP among perimenopausal women was 7.1%. Commonly practiced treatment for MSP includes, NSAIDS, COX-2 inhibitors and corticosteroid injections. Above said NSAIDS etc. provide short term relief from pain but their extended use over a period of time has various adverse effects such as MI, atrial fibrillation, acute renal dysfunction, GI bleeding etc. time Research Question: Is Anuvasna Basti effective in Sarvangavata with special reference to musculoskeletal pain in perimenopausal/postmenopausal phase. Hypothesis: Anuvasna Basti is not effective in Sarvangavata with special reference to musculoskeletal pain in perimenopausal/postmenopausal phase. Null Hypothesis (H0): Anuvasna Basti is effective in Sarvangavata with special reference to musculoskeletal pain in perimenopausal/postmenopausal phase. Aim: The aim of the study is to explore a short-term intervention which may be repeated frequently to arrest the MSP in peri and post-menopausal phase of women. Objective of the study:To evaluate the change in Numerical rating score (NRS) for musculoskeletal pain.To evaluate the change in quality of life in peri and post-menopausal phase of women. |