| CTRI Number |
CTRI/2025/01/078887 [Registered on: 17/01/2025] Trial Registered Prospectively |
| Last Modified On: |
28/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurvedic Management of Sciatica. |
|
Scientific Title of Study
|
A randomized control clinical study to evaluate the effect of Agnikarma and Kala Basti by Erandmooladi Niruha and Saindhavadi Anuvasana in the management of Gridhrasi |
| 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 Shiwani Raturi |
| Designation |
PG Scholar |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Room No 123,PG Department of Panchakarma, Chaudhary Brahm Prakash Ayurved Charak Sansthan ,Khera Dabar South West Delhi 110073 India
South West
DELHI
110073
India |
| Phone |
7055080396 |
| Fax |
|
| Email |
raturishiwani95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anup Jain |
| Designation |
Assistant Professor |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Room No 141,PG Department of Panchakarma, Chaudhary Brahm Prakash Ayurved Charak Sansthan ,Khera Dabar South West Delhi 110073 India
South West
DELHI
110073
India |
| Phone |
9818870321 |
| Fax |
|
| Email |
dr.anupjain@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anup Jain |
| Designation |
Assistant Professor |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Room No 141,PG Department of Panchakarma, Chaudhary Brahm Prakash Ayurved Charak Sansthan ,Khera Dabar South West Delhi 110073 India
Room No 141,PG Department of Panchakarma, Chaudhary Brahm Prakash Ayurved Charak Sansthan ,Khera Dabar South West Delhi 110073 India
South West
DELHI
110073
India |
| Phone |
9818870321 |
| Fax |
|
| Email |
dr.anupjain@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chaudhary Brahm Prakash Ayurved Charak Sansthan,Khera Dabar,Najafgarh,New Delhi,India,Pincode 110073 |
|
|
Primary Sponsor
|
| Name |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Khera Dabar,Najafgarh,New Delhi-110073 |
| 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 Anup Jain |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
OPD and IPD,PG Department of Panchakarma, Chaudhary Brahm Prakash Ayurved Charak Sansthan ,Khera Dabar Najafgarh,New Delhi 110073 India
South West
DELHI |
9818870321
dr.anupjain@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-Chaudhary Brahm Prakash Ayurved Charak Sansthan |
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 | Comparator Arm | Procedure | - | kAla-bastiH, काल-बसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Charak Chikitsa Vatavyadhichikitsa (28/101}, Procedure details: Pre Basti Management (Purva Karma)
Written informed consent will be taken.
Deepan-Pachana: Chitrakadi vati 250mg tablets BD (after meals)
Patient will be instructed to take a light diet before Anuvasan Basti.
On the day of Niruha Basti , Sthanik Snehana with Til taila and Sthanik Swedan will be done at low back and hypogastrium region.
The patient will be instructed for bowel and bladder evacuation before administration of Basti.
Pradhana Karma –
Administration of Niruha Basti:
Position: Left lateral position (left leg straight and right leg folded)
Basti Putaka to be filled with Basti Dravya and Basti Netra will be attached to it. Basti Netra passage will filled to avoid savata basti daana.
Til tail will be applied to anal opening and Basti Netra. 4 Angul of Basti Netra will be introduced per rectum and Basti Dravya will be administered.
Basti Netra will be removed from the anus slowly.
Administration of Anuvasana Basti:
Anuvasana Basti will be given just after having meal.
Position: Left lateral position (left leg straight and right leg folded).
Saindhavadi tail will be filled in syringe and connected with catheter. Tip of catheter will be lubricated with oil.
The catheter will be introduced into the anus gently upto 4 Angula and piston of the syringe will be pressed slowly with uniform pressure to push the tail into the rectum.
After removing catheter patient will be advised to lie down in supine position with hands and legs freely spread over the table.
Paschat Karma:
The patient will be asked to lie down comfortably -sapadapitha shayana (supine position).
Sphika tadan (only after anuvasana basti).
Basti Pratyagaman will be observed by Prashna Pariksha.
After Basti Pratyagaman pt. will be advised to take rest and Laghu ahara.
)
(1) Medicine Name: Erandmooladi , Reference: Charak Siddhisthan bastisutriyasiddhi (3/38-42), Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 480(ml), Frequency: od, Duration: 6 Days | | 2 | Intervention Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Charak Chikitsa Vatavyadhichikitsa (28/101), Procedure details: ➢ Agnikarma will be done after the patient has taken Pichhila food.
1. Purva Karma (Pre-operative procedure)
a. Proper instrumentation (Agropaharaniyani)
 The Agnikarma room will be well prepared with all required Agropaharaniyani described by Acharya Sushruta.
b. Prepare Haridra mixed water for cleaning the local part of the patient.
b. Material required for the procedure - Yashtimadhu Churna, small pieces of Kumari Patra, swab holding forceps, Plota (gauze piece), Pichu (cotton), & gas stove, Panchloha Shalaka. etc. are kept ready for use. The Shalaka is heated up to become red hot on fire.
ï¶ After carefully considering the symptoms of the disease, the vital spots & strength of the patient, disease, & seasons, the procedure will be started.
Following factors will be kept in mind i.e:
• Sharira Rachana (Anatomy) of disease part
• Rugna Bala
• Knowledge of Marma at the disease part
• Knowledge of disorder
• Knowledge of Ritukala
2. Pradhana Karma:
a. Type of Agnikarma - Bindu will be made.
b. By Panchloha Shalaka in red hot condition, exposure time 1 second & creating specific sound“Chitâ€.
Paschaata Karma:
a. After Agnikarma application of aloe vera pulp & Yastimadhu Churna on the burned site.
b. Application of bandage for 24-48 hours & advice to protect it from getting wet or any contamination. Pathya-Apathya is advised as per Sushruta’s Vrana Rogadhikara.
)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of Gridhrasi irrespective of its subtypes
The presence of Ruka, Toda, Stambha, and Spandana in the Sphika, Kati, Uru, Janu, Jangha,
and Pada.
Presence of Ruka, Toda and Stambha along with Tandra, Gaurav, and Arochaka.
Positive SLR test |
|
| ExclusionCriteria |
| Details |
1. Contraindicated for Basti Karma and Agnikarma
2. Known case of any Major Illness: Potts Disease, AIDS, Malignancy.
3. Cases of Spondylolisthesis, Sacroiliac Arthritis, and Herpes Simplex infection causing
radiating pain.
4. Debilitated patients, patients affected with multiple wounds, and cases with vertebral
fractures.
5. Pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Kala Basti followed by Agnikarma may show better result in reducing ruk and stambha in case of Gridhrasi when compared to Kala Basti by Erandmooladi Niruha and Saindhavadi Anuvasana |
0th Day, 30th Day, 48th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Kala Basti followed by Agnikarma may or may not show better result in reducing Ruk and Stambha in case of Gridhrasi when compared to Erandmooladi Niruha and Saindhavadi Anuvasana |
0th Day,30th Day, 48th Day |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 3 |
|
Date of First Enrollment (India)
|
28/01/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 study is a randomized control trial to evaluate the effect of Kala Basti followed by Agnikarma in the management of classic symptoms of Gridhrasi when compared to Kala Basti by Erandmooladi Niruh and Saindhavadi Anuvasana.In one group Kala Basti (Erandmooladi Niruh and Saindhavadi Anuvasan) will be given followed by 3 sittings of Agnikarma once a week. The first assessment on 0th Day, the Second Assessment on procedure completion 30th Day and follow-up on the 48th Day. While in the second group only Kala Basti ( Erandmooladi Niruh and Saindhvadi Anuvasan) will be given. The first assessment on 0th Day, the Second Assessment on procedure completion 16th Day, and follow-up on the 48th Day. Patients will be enrolled in Chaudhary Brahm Prakash Ayurved Charak Sansthan OPD and IPD of PG Department of Panchakarma. Kala Basti followed by Agnikarma may show better results in reducing classic symptoms of Gridhrasi like ruka and stambha. Improvement in ODI scale and SLR are expected to be observed |