| CTRI Number |
CTRI/2025/02/080960 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
25/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Ayurveda treatment in back pain |
|
Scientific Title of Study
|
Efficacy of Prasaranyadi taila Anuvasana basti in the
Management of Gridhrasi (w.s.r. to Sciatica) – A Randomized controlled clinical trial
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NOT APPLICABLE. |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yashraj Yugmandhar Doshi |
| Designation |
PG Scholar |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya |
| Address |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi
Belgaum KARNATAKA 590003 India |
| Phone |
7720903993 |
| Fax |
|
| Email |
yashrajd15@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rajashekhar Sanapeti |
| Designation |
Professor & HoD |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya |
| Address |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi
Belgaum KARNATAKA 590003 India |
| Phone |
9611442881 |
| Fax |
|
| Email |
rajashekharpk@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Rajashekhar Sanapeti |
| Designation |
Professor & HoD |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya |
| Address |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi
KARNATAKA 590003 India |
| Phone |
9611442881 |
| Fax |
|
| Email |
rajashekharpk@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi - 590003 |
|
|
Primary Sponsor
|
| Name |
Dr Yashraj Yugmandhar Doshi |
| Address |
KAHERs Shri B. M. Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi - 590003 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NOT APPLICABLE |
NOT APPLICABLE |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Yashraj Doshi |
KLE AYURVEDA HOSPITAL & MRC |
OPD no 04 and IPD Department of Panchakarma KLE AYURVEDA HOSPITAL & MRC Shahapur Belagavi - 590003 Belgaum KARNATAKA |
7720903993
yashrajd15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Insitutional Ethics Committee for Research on Human Subjects KAHERs Shri B. M. Kankanawadi Ayurveda Mahavidyalaya & KLE Ayurved Hospital, Shahapur, Belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M543||Sciatica. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | anuvAsana-bastiH, अनुवासन-बस्तिः | (Procedure Reference: , Procedure details: Mild purgation of day 1 followed by
Rectal route of drug administration with Prasaranyadi Taila 75ml for 7 days)
| | 2 | Comparator Arm | Procedure | - | anuvAsana-bastiH, अनुवासन-बस्तिः | (Procedure Reference: , Procedure details: Mild purgation of day 1 followed by
Rectal route of drug administration with Sahacharadi Taila 75ml for 7 days)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient fulfilling the diagnostic criteria
Patient who is fit for Basti.
Patients who are indicated for Anuvasana Basti
|
|
| ExclusionCriteria |
| Details |
History of spinal surgery and vertebral fracture.
Evidence of systemic diseases like uncontrolled diabetes, Hypertension, Ischemic heart disease, etc
Established tumors/malignancy.
Pregnant and lactation women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prasaranyadi Taila Anuvasana Basti is effective in reducing pain in Gridhrasi. |
0th Day, 8th Day and 23rd Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NOT APPLICABLE |
NOT APPLICABLE |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
03/03/2025 |
| 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 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 most common musculoskeletal disorder affecting the movement of leg is low back pain. Among the affected patients, 40% have radicular pain and these cases can be classified under the umbrella term of sciatic syndrome. Low back pain is extraordinarily common, second only to the common cold.[1] The prevalence of Sciatica varies from 1.2% to 43% in different studies, and about 50% of working adults experience a back injury each year. Lifetime incidence is reported to be between 10% to 40% and an annual incidence of sciatica ranges from 1 to 5%. [2] Sciatica is characterized by excruciating pain and paresthesias in sciatic nerve distribution associated lumbosacral nerve root which severely affects the quality of life of those affected.[3] Physical activity during work and occupational workload, such as lifting heavy objects twisting the trunk while working, or being exposed to whole-body vibration (for example, machine operators or motor vehicle drivers), are all potential risk factors for Sciatica. These factors can create pressure on the spinal cord, leading to lower back pain and radiating pain.[4] In modern medicine, muscle relaxants, NSAIDs, corticosteroids, and other medications are often used to provide temporary pain relief. However, surgery may be required as a last resort, which can result in various complications and even permanent loss of working capabilities.[5] In Ayurveda, sciatica seems to similar in signs and symptoms with Gridhrasi. Gridhrasi is a condition where the pain starts in the sphik pradesh area and radiates downwards to kati, prusta, uru, janu, jangha, and pada. Sciatica is a common cause of pain and disability and is more severe and persistent than low back pain In this disease, mainly Vyana Vayu vitiation is observed, but Kapha is usually associated with Dosha.[6] So for the treatment of Gridhrasi, the drug of choice should have Vatashamaka, Kaphashamaka, Vatanulomaka, Dipana-Pachana(digestive-carminative), and Shulaprashamana properties. Vasti is recommended as the best treatment for Vata because of how closely the Vata dosha and neurological system operate. It again validates the efficacy of Vasti karma on the nervous system. Charaka mentions that the administration of Anuvasana Vasti results in the nourishment of all pathways once it reaches Nabhipradesh, which is the central location of Sira(vessels) and Dhamani(channels).[7] According to Bhaishyajya Ratnavali, in the Phalashruthi of Kubja Prasaranyadi Taila, Gridhrasi has been mentioned, Because it balances the vata and kapha doshas, Pratisarini taila is a useful taila for Anuvasna basti. The quality of Prasaranyadi taila is described as "Vatashleshmabhayan jayet" in Bhaishjya Ratnavali.[8] The components of prasaranyadi taila consist of kaphavatahara, katu tikta, kashaya, rastmak dravya. Sahacharadi taila has been proven effective and widely used for conditions involving Gridhrasi. Prasaranyadi taila has Vatahara and Kaphahara properties. Prasaranyadi taila also contains Saindhav, Bhallatak, Jatamansi, Dadhi, and Kanji. Therefore, this study aims to determine whether the property of Prasaranyadi taila will be more effective in treating Gridhrasi compared to Sahacharadi taila. |