| CTRI Number |
CTRI/2025/09/095061 [Registered on: 18/09/2025] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the Effect of Vaitarana Basti alone and with Agnikarma in the management of sciatica pain in 60 participants. |
|
Scientific Title of Study
|
Comparative clinical evaluation of vaitarana basti with and without agnikarma in gridhrasi (sciatica) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
LALIT KUMAR |
| Designation |
PG SCHOLAR PANCHKARMA |
| Affiliation |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN, HARIDWAR, UTTARAKHAND |
| Address |
DEPARTMENT OF PANCHKARMA PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN, HARIDWAR, UTTARAKHAND
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9319121391 |
| Fax |
|
| Email |
lalitmanwal1983@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHIVANI MAHAJAN |
| Designation |
PROFESSOR |
| Affiliation |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN, HARIDWAR, UTTARAKHAND |
| Address |
DEPARTMENT OF PANCHKARMA PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN, HARIDWAR, UTTARAKHAND
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9760376761 |
| Fax |
|
| Email |
shivani.mahajan@divyayoga.com |
|
Details of Contact Person
Public Query
|
| Name |
LALIT KUMAR |
| Designation |
PG SCHOLAR PANCHKARMA |
| Affiliation |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN, HARIDWAR, UTTARAKHAND |
| Address |
DEPARTMENT OF PANCHKARMA PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN, HARIDWAR, UTTARAKHAND
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9319121391 |
| Fax |
|
| Email |
lalitmanwal1983@gmail.com |
|
|
Source of Monetary or Material Support
|
| PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN
|
|
|
Primary Sponsor
|
| Name |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN |
| Address |
PATANJALI YOGPEETH PHASE 1 PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN BAHADARABAD |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN |
PATANJALI YOGPEETH PHASE 1 PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN BAHADARABAD |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| LALIT KUMAR |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN BAHADARABAD |
PANCHKARMA DEPARTMENT OPD 4 AND 23
Hardwar
UTTARANCHAL |
9319121391
lalitmanwal1983@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE PATANJALI AYURVEDA COLLEGE |
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 | - | agnikarma, अग्निकर्म vaitaraNa-bastiH, वैतरण-बस्ति | (Procedure Reference: VAITARANA BASTI- वंगसेन संहिता 91/186-190 ,AGNIKARMA - च.चि. 28/101, Procedure details: (Procedure Reference: VAITARANA BASTI- वंगसेन संहिता 91/186-190 ,AGNIKARMA - च.चि. 28/101, Procedure details: VAITARANA BASTI : POORVA KARMA : After passing faeces , urine and flatus , the patient on empty stomach should be prepared with Abhyanga and Swedan. However, patient should not be very hungry. PRADHANA KARMA: Patient will be asked to lie down comfortably on his left side to keep his head on his arms in the form ofpillow while keeping the body straight and relaxed. Then the patient will be asked to flex his right leg over his fully extended left leg. There after anus and enema nozzle will be lubricated with oil. After removing air bubble, appropriate quantity of prepared Niruha Basti will be administered. PASCHAT KARMA : Patient will be advised to lie on his back i.e in supine position comfortably on the bed. Patient will be advised to empty his bowel after getting urge for defecation. ANUVASANA BASTI : POORVA KARMA : Patient will be given Abhyanga and Swedan followed with warm water bath And then patient will be advised to take food less by ¼ of the usual quantity. Ask patient to eliminate feaces , urine or flatus if present. PRADHANA KARMA : Patient will be asked to lie down comfortably on his left side to keep his head on his arms in the form ofpillow while keeping the body straight and relaxed. Then the patient will be asked to flex his right leg over his fully extended left leg. Thereafter anus and enema nozzle will be lubricated with oil. After removing air bubble, appropriate quantity of prepared Anuvasana Basti will be administered. PASCHAT KARMA : Buttocks of the patient will be patted with palms for 3 times and will be advised to relax in supine position. Patient will be advised to empty his bowel after getting urge for defecation in squatting position. AGNIKARMA POORVA KARMA : In all seasons and diseases with temperature-controlled environment and after Snigdha and Pichhila Diet. PRADHANA KARMA : Agnikarma shalaka will be heated prior to procedure. 5-30 bindu samyaka dagdh by panchadhatu shalaka on tender point of lumbso sacral area. 5-15 bindu samyaka dagdh by panchadhatu shalaka on Achilles tendon’s both side. PASCHAT KARMA: After Agnikarma samyaka dagdh vrana ropan will be done by Ghritkumari . Application of Ghrit and madhu on samyaka dagdh vrana from very next day upto a week . DURATION VAITARANA BASTI WILL BE GIVEN IN YOG BASTI SCHEDULE i.e, for 8 days and Agnikarma will be done on 9th day))
(1) Medicine Name: agnikarma, अग्निकर्म vaitaraNa-bastiH, वैतरण-बस्ति, Reference: VAITARAVAITARANA BASTI- वंगसेन संहिता 91/186-190 ,AGNIKARMA - च.चि. 28/101, , Route: Topical, Dosage Form: Not Applicable, Dose: 10(NA), Frequency: od, Duration: 9 Days | | 2 | Comparator Arm | Procedure | - | vaitaraNa-bastiH, वैतरण-बस्ति | (Procedure Reference: VAITARANA BASTI- वंगसेन संहिता 91/186-190, Procedure details: VAITARANA BASTI :
POORVA KARMA : After passing faeces , urine and flatus , the patient on empty stomach should be prepared with Abhyanga and Swedan. However, patient should not be very hungry. PRADHANA KARMA: Patient will be asked to lie down comfortably on his left side to keep his head on his arms in the form ofpillow while keeping the body straight and relaxed. Then the patient will be asked to flex his right leg over his fully extended left leg. There after anus and enema nozzle will be lubricated with oil. After removing air bubble, appropriate quantity of prepared Niruha Basti will be administered. PASCHAT KARMA : Patient will be advised to lie on his back i.e in supine position comfortably on the bed. Patient will be advised to empty his bowel after getting urge for defecation. ANUVASANA BASTI : POORVA KARMA : Patient will be given Abhyanga and Swedan followed with warm water bath And then patient will be advised to take food less by ¼ of the usual quantity. Ask patient to eliminate feaces , urine or flatus if present.
PRADHANA KARMA : Patient will be asked to lie down comfortably on his left side to keep his head on his arms in the form ofpillow while keeping the body straight and relaxed. Then the patient will be asked to flex his right leg over his fully extended left leg. Thereafter anus and enema nozzle will be lubricated with oil. After removing air bubble, appropriate quantity of prepared Anuvasana Basti will be administered.
PASCHAT KARMA : Buttocks of the patient will be patted with palms for 3 times and will be advised to relax in supine position. Patient will be advised to empty his bowel after getting urge for defecation in squatting position.
DURATION
VAITARANA BASTI WILL BE GIVEN IN YOG BASTI SCHEDULE i.e, for 8 days )
(1) Medicine Name: VAITARANA BASTI, Reference: VAITARANA BASTI- वंगसेन संहिता 91/186-190, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 312(ml), Frequency: od, Duration: 8 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient present with clinical features of Gridhrasi.
Patient of either sex between age group of 18 to 60 years.
Patients were selected irrespective of sex, occupation, socio economic status, religion etc.
Patient fit for Agni Karma will be taken for the study.
Patient fit for Basti Karma will be taken for the study. |
|
| ExclusionCriteria |
| Details |
Patients below the age of 18 years and above 60 years were excluded.
Patient with metabolic disorder, hypertension, systemic disorders.
Patient with Tuberculosis of Spine and Hip Joint
Patients who are pregnant and lactating mother. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
PARAMETERS THAT WILL BE ASSESSED :
1.Ruka (Pain)
2.Stambha (Stiffness)
3.Aruchi (Anorexia)
4.Spanadana (Pulsating/Throbbing sensation)
5.Gaurav (Heaviness)
6.Toda (Pricking Sensation)
7.Tandra (Sleepiness)
8.Supti (Numbness)
|
9,30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SLR |
9,30 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
|
Phase 2 |
|
Date of First Enrollment (India)
|
29/09/2025 |
| 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="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
This study is Comparative clinical evaluation of vaitarana
basti with and without Agnikarma in gridhrasi (sciatica)
This will be conducted on 60 randomly selected patients from Opd/Ipd of Panchakarma department of Patanjali Bhartiya Ayurvigyan evum Anusandhan Sansthan Haridwar. Patient will be divided into 2 groups- 30 patients will be administered vaitarana basti with agnikarma and 30 patients will be administered vaitarana basti without agnikarma in yog basti schedule. Follow up will be taken after 1 month assessment to be done on the basis of subjective and objective parameters as discussed earlier. |