| CTRI Number |
CTRI/2025/09/095176 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
20/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
To evaluate the effect of Chaturbhadra kalpa basti krama and Kalabasti krama in the management of Katigraha with special reference to Lumbar Spondylosis |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the effect of Chaturbhadra kalpa basti krama and Kalabasti krama in the management of Katigraha with special reference to Lumbar Spondylosis |
| 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 Amruta Vasant Pednekar |
| Designation |
PG SCHOLAR |
| Affiliation |
R. A. PODAR AYURVED MEDICAL COLLEGE, WORLI, MUMBAI |
| Address |
Panchakarma Department, R. A. Podar Ayurvedic Medical College, Dr. Annie Besant Road, Worli, Mumbai- 400018
Mumbai
MAHARASHTRA
400018
India |
| Phone |
8692962675 |
| Fax |
|
| Email |
amrutape@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sheetal Lodha |
| Designation |
Associate Professor |
| Affiliation |
R. A. PODAR AYURVED MEDICAL COLLEGE, WORLI, MUMBAI |
| Address |
OPD no 7, Panchakarma Department ,M. A. Podar Ayurved Hospital, Dr. Annie Besant Road, Worli, Mumbai- 400018
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9920792037 |
| Fax |
|
| Email |
vd.sheetal4u@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sheetal Lodha |
| Designation |
Associate Professor |
| Affiliation |
R. A. PODAR AYURVED MEDICAL COLLEGE, WORLI, MUMBAI |
| Address |
OPD no 7, Panchakarma Department, M. A. Podar Ayurved hospital, Dr. Annie Besant Road, Worli, Mumbai- 400018
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9920792037 |
| Fax |
|
| Email |
vd.sheetal4u@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| M. A. Podar Medical Hospital, Dr. Annie Besant Road, Worli, Mumbai |
|
|
Primary Sponsor
|
| Name |
R. A. Podar Ayurvedic Medical College, Worli, Mumbai |
| Address |
Panchakarma Department, R. A. Podar Ayurvedic Medical College,Annie Besant Road, Worli, Mumbai- 400018 |
| 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 |
| Dr Amruta Vasant Pednekar |
M. A. Podar Ayurvedic Hospital, Worli, Mumbai |
Panchakarma Department, R. A. Podar Ayurvedic Medical College, Dr. Annie Besant Road, Worli, Mumbai- 400018
Panchakarma Department, R. A. Podar Ayurvedic Medical College, Dr. Annie Besant Road, Worli, Mumbai- 400018
Mumbai
MAHARASHTRA |
08692962675
amrutape@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BORS COMMITTEE OF INSTITUTION, R A PODAR GOVERNMENT AYU COLLEGE, WORLI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M471||Other spondylosis with myelopathy. Ayurveda Condition: VATAVYADHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Ashanga Hridaya Sutrasthan 19/64, Procedure details: Kalabasti Kram i.e. Firstly One Anuvasan Basti, Then alternately One Niruaha & One Anuvasan for Eleven Days i.e. Five Anuvasan and Six Niruha And Lastly Three Anuvasan Basti. This means total 15 days basti kram)
(1) Medicine Name: Shatipushkaradi Tail, Reference: Sushrut Chikitsa 38/8-10, Route: Rectal, Dosage Form: Taila, Dose: 80(ml), Frequency: od, Duration: 9 Days(2) Medicine Name: Shatipushkaradi Kwath, Reference: Sushrut Chikitsa 38/8-10 , Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 760(ml), Frequency: od, Duration: 6 Days | | 2 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Kashyap Khilasthan 8/23, Procedure details: Chaturbhadra Kalabasti Kram i.e. Firstly Four Anuvasan Basti, Then Four Niruha Basti, Then Four Anuvasan Basti, Total 12 days of basti kram)
(1) Medicine Name: Shatipushkaradi Tail, Reference: Sushrut Chikitsa 38/8-10, Route: Rectal, Dosage Form: Taila, Dose: 80(ml), Frequency: od, Duration: 8 Days(2) Medicine Name: Shatipushkaradi Kwath, Reference: Sushrut Chikitsa 38/8-10 , Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 760(ml), Frequency: od, Duration: 4 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient having classical sign and symptoms of katigraha such as pain (shool) and stiffness (stambha).
2.Indications of Niruh and Anuvasan basti.
3.Patients fulfilling the selection criteria and between the age of 30 to 70 years.
4.Degenerative changes evident on X-ray LS spine. |
|
| ExclusionCriteria |
| Details |
1.Fracture of lumbar spine.
2.Patient who not fit for basti (Bleeding piles, Rectal prolapse)
3.Children and Pregnant women, lactating mother and during menstrual cycle
4.Patients with other joint deformities or diseases such as TB of spine, spinal abnormality, congenital scoliosis.
5.Patients with rheumatoid arthritis will be excluded from the study.
6.Patients with immunocompromised disease, psychiatric diseases.
7.Patients taking oral pain killers, NSAID’s or Ayurvedic drug for pain and patients undergoing any local karma like lepa, upnah, agnikarma etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in subjective and objective criteria like VAS scale, lumbar flexion measurement, lumbar extension measurement, SLRT |
4-5 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in stiffness |
4-5 weeks |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
15/10/2025 |
| 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
|
Title of Study
Comparative Clinical Study to evaluate the effect of Chaturbhadra Kalpa Basti Kram and Kala Basti Kram in the management of Katigraha with special reference to Lumbar Spondylosis.
Background
Katigraha is a condition of low back pain caused by vitiated Vata dosha.
Lumbar Spondylosis is its modern equivalent—characterized by degeneration of lumbar spine with pain and stiffness.
Basti karma (medicated enema) is the primary treatment for Vata disorders in Ayurveda.
Objective
To compare the effectiveness of Chaturbhadra Kalpa Basti (12-day Anuvasan-dominant schedule) vs. Kala Basti (15-day classical schedule of alternating Anuvasan and Niruha basti) in reducing signs and symptoms of Katigraha w.s.r. Lumbar Spondylosis.
Methods Study Type: Comparative Clinical Trial Sample Size: 62 patients (31 in each group) Drugs Used: Shatipushkaradi Tail (Anuvasan Basti) Shatipushkaradi Kwath (Niruha Basti)
Assessment: Subjective: Pain scale (VAS), Coin test Objective: Lumbar flexion/extension, SLRT (Straight Leg Raise Test)
Inclusion Criteria Age 30–70 years Diagnosed lumbar spondylosis (X-ray) Classical signs of Katigraha (pain, stiffness)
Exclusion Fractures, TB spine, RA, pregnancy, other joint deformities
Basti Protocols- Chaturbhadra Kalpa Basti Group A 4 Anuvasan - 4 Niruha - 4 Anuvasan over 12 days
Kala Basti Group B Standard kala basti kram for 15 days
Results Expected - Chaturbhadra Kalpa Basti is hypothesized to be more effective due to its bruhana (nourishing) nature, especially for chronic degenerative Vata conditions like katigraha. |