| CTRI Number |
CTRI/2026/01/102215 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
27/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate ayurvedic enema therapy for low back pain. |
|
Scientific Title of Study
|
A Randomized Controlled Trial to evaluate the efficacy of Hapushadi Yapana Basti with Tila Taila Matra Basti in the management of Sandhigata Vata with special reference to Katishoola. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nikita Narendra Lunkad |
| Designation |
MD Panchakarma Scholar |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
OPD No.6,Panchakarma Department, Ground floor, MAMs Sumatibhai Shah Ayurved Mahavidyalaya, Sane Guruji Arogya Kendra, Malwadi Hadapsar, Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9673515513 |
| Fax |
|
| Email |
nikitalunkad9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Maya Gokhale |
| Designation |
Head of department of Panchakarma |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya Pune |
| Address |
OPD No.6,Panchkarma Department, Ground floor, MAMs Sumatibhai Shah Ayurved Mahavidyalaya, Sane Guruji Arogya Kendra, Malwadi Hadapsar, Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9422323285 |
| Fax |
|
| Email |
drmayagokhale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Maya Gokhale |
| Designation |
Head of department of Panchakarma |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya Pune |
| Address |
OPD No.6,Panchkarma Department, Ground floor, MAMs Sumatibhai Shah Ayurved Mahavidyalaya, Sane Guruji Arogya Kendra, Malwadi Hadapsar, Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9422323285 |
| Fax |
|
| Email |
drmayagokhale@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Panchakarma, Sane Guruji Arogya Kendra Malwadi Hadapsar Pune 411028 |
|
|
Primary Sponsor
|
| Name |
Sane Guruji arogya Kendra |
| Address |
Sane Guruji arogya Kendra
Malwadi Hadapsar Pune Maharashtra 411028 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Nikita Lunkad |
Sane Guruji arogya Kendra |
OPD No.6, Department of Panchakarma
Pune
MAHARASHTRA |
9673515513
nikitalunkad9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAMs Sumatibhai Shah Ayurveda Mahavidyala & Sane Guruji Arogya Kendra Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M00-M99||Diseases of the musculoskeletal system and connective tissue. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Charak samhita, Procedure details: Hapushadi Yapana Basti will be prepared as per SOP.)
(1) Medicine Name: Hapusha, Reference: Charak Samhita, Route: Rectal, Dosage Form: Ksheerpaka, Dose: 240(ml), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Charak Samhita, Procedure details: Tila Taila Matra Basti will be given as per the SOP of anuvasana basti administration.)
(1) Medicine Name: Tila taila, Reference: Charak Samhita, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Basti arha
Patients diagnosed with Katishoola.
Patients with non-specific, mechanical, or degenerative low back pain (e.g.,
k/c/o lumbar spondylosis, myofascial pain, postural LBP).
|
|
| ExclusionCriteria |
| Details |
Patients having congenital structural deformities.
Patients having other joint deformities or diseases which are not related to
Katishoola.
K/C/O Sciatica will be excluded.
Neurological signs of radiculopathy, spinal trauma, infection, malignancy,
severe stenosis.
Patients with systemic disease which may cause interference in the
treatment of study will be excluded.
o Pregnant women. |
|
|
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 |
To evaluate the efficacy of Hapushadi Yapana Basti when compared with Tila
Taila Matra Basti in the management of Sandhigata Vata with special
reference to Katishoola for 7 days. |
Treatment will be given for 7 days to both groups. Patient will be assessed on 7th day . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
16/02/2026 |
| 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="6"
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
|
This is randomized controlled trial to evaluate the efficacy of Hapushadi Yapana Basti by comparing with the control drug Tila taila matra basti. Trial group will be given Hapushadi yapana basti from 2nd to 6th day and tila taila matra basti will be given on 1st and 7th day. Control group will be given Tila taila matra basti for continuous 7 days. Observations will be drawn from outcome of patient. |