CTRI Number |
CTRI/2023/08/056604 [Registered on: 17/08/2023] Trial Registered Prospectively |
Last Modified On: |
14/08/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
A study to compare the efficacy of Kashyapokta Kala Basti and Vagbhatokta Kala Basti in the management of Vataja Gridhrasi or Sciatica. |
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of Kashyapokta Kala Basti and Vagbhatokta Kala Basti in the management of Vataja Gridhrasi vis-a-vis 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 |
Dr Sreejith R |
Designation |
PG Scholar |
Affiliation |
Sri Sri College Of Ayurvedic Science And Research, Bangalore. |
Address |
Room No-8,Panchakarma OPD,
Sri Sri College of Ayurvedic Science and Research Hospital,21st K.M Kanakapura Road Udayapura, Bangalore.
Bangalore KARNATAKA 560082 India |
Phone |
09895715110 |
Fax |
|
Email |
sreerejit@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Ganesh Puttur |
Designation |
Principal and HOD |
Affiliation |
Sri Sri College Of Ayurvedic Science And Research, Bangalore. |
Address |
Room No-8,Panchakarma OPD,
Sri Sri College of Ayurvedic Science and Research Hospital,21st K.M Kanakapura Road Udayapura, Bangalore.
Bangalore KARNATAKA 560082 India |
Phone |
9538176059 |
Fax |
|
Email |
drganeshputtur@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Ganesh Puttur |
Designation |
Principal and HOD |
Affiliation |
Sri Sri College Of Ayurvedic Science And Research, Bangalore. |
Address |
Room No-8,Panchakarma OPD,
Sri Sri College of Ayurvedic Science and Research Hospital,21st K.M Kanakapura Road Udayapura, Bangalore.
Bangalore KARNATAKA 560082 India |
Phone |
9538176059 |
Fax |
|
Email |
drganeshputtur@gmail.com |
|
Source of Monetary or Material Support
|
Sri Sri College Of Ayurvedic Science And Research Hospital, Bangalore. |
|
Primary Sponsor
|
Name |
Dr Sreejith R |
Address |
Sri Sri College Of Ayurvedic Science And Research, Bangalore. |
Type of Sponsor |
Other [SELF] |
|
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 Sreejith R |
Sri Sri College Of Ayurvedic Science And Research Hospital, Bangalore. |
Room No-8,Panchakarma OPD Bangalore KARNATAKA |
9895715110
sreerejit@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
SRI SRI INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:G55||Nerve root and plexus compressionsin diseases classified elsewhere. Ayurveda Condition: GRUDHRASIÂ (KEVALAVATA), |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•रà¥à¤®/वसà¥à¤¤à¤¿à¤•रà¥à¤® | (Procedure Reference: Ashtanga Hrudaya Sutra Sthana 19, Procedure details: GROUP A- KASHYAPOKTA KALA BASTI
Niruha basti – Ardhamatrika basti-596 ml
Anuvasana basti – Sahacharadi taila-72ml
Day 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
Type of Basti A A A N A A A N A A A N A A A
I. ANUVASANA BASTI
POORVAKARMA
Preparation of Basti Yanta & Basti Netra – 100ml syringe along with the rubber catheter fitted to the free end of the syringe will be used for Anuvasana Basti. The mentioned quantity of medicine is indirectly warmed and is filled inside the sterile syringe) (1) Medicine Name: Ardhamatrika Basti, Reference: Vangasena Samhita,Bastikarmaadhikara, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 596(ml), Frequency: od, Duration: 3 Days(2) Medicine Name: Sahacharadi taila, Reference: Ashtanaga Hrudaya Chikitsa Sthana 21, Route: Rectal, Dosage Form: Taila, Dose: 72(ml), Frequency: od, Duration: 12 Days | 2 | Intervention Arm | Procedure | - | bastikarma, बसà¥à¤¤à¤¿à¤•रà¥à¤® | (Procedure Reference: Ashtanga Hrudaya Sutra 19, Procedure details: GROUP B- VAGBHATOKTA KALA BASTI
Niruha basti - Ardhamatrika basti-596 ml
Anuvasana basti – Sahacharadi taila-72ml
Day 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
Type of Basti A N A N A N A N A N A N A A A
I. ANUVASANA BASTI
POORVAKARMA
Preparation of Basti Yanta & Basti Netra – 100ml syringe along with the rubber catheter fitted to the free end of the syringe will be used for Anuvasana Basti. The mentioned quantity of medicine is indirectly warmed and is filled inside the sterile syringe. ) (1) Medicine Name: Ardhamatrika Basti, Reference: Vangasena samhita Bastikarmadhikara, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 596(ml), Frequency: od, Duration: 6 Days(2) Medicine Name: Sahacharadi Taila, Reference: Ashtanga Hrudaya Chikitsa Sthana 21, Route: Rectal, Dosage Form: Taila, Dose: 72(ml), Frequency: od, Duration: 9 Days |
|
|
Inclusion Criteria
|
Age From |
21.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
-Subjects between the age group of 21 - 60 years irrespective of gender, religion, occupation and socioeconomic status.
-Subjects fit for Basti Karma.
-Subjects presenting with clinical signs and symptoms of Vataja Gridhrasi.
-Subjects who are willing to give a written consent for the treatment.
|
|
ExclusionCriteria |
Details |
-Subjects below 21 years and above 60 years of age.
-Subjects unfit for Basti Karma.
-Subjects presenting with signs and symptoms of Vata-Kaphaja Gridhrasi.
-Systemic diseases which interfere with the course of treatment will be excluded.
-Subjects with spinal deformity, severe traumatic injury, tuberculosis of the spine, benign or malignant tumors of spine.
-Pregnant and lactating women.
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Alternation |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
SLR Test, VAS scale for pain assessment, Oswestery low back disability index |
0th day,15th day,45th day |
|
Secondary Outcome
|
Outcome |
TimePoints |
Nil |
Nil |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
28/08/2023 |
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
|
In the present era, there is considerable increase in
disorders related to the locomotory system which has affected both social and professional
life of human, impairing the quality of living. ‘Gridhrasi’ is one among
such disorders described in Ayurvedic classics. It is a Ruja Pradhana Vatavyadhi
and the name ‘Gridhrasi’ itself indicates the impaired gait
of the patient i.e., “Gridhravathâ€. In Gridhrasi, there is intense
shooting pain characteristically radiating from Sphik (gluteal region)
to Prishtha Bhaga of Kati (lumbo-sacral region), Uru, Janu,
Jangha and Pada in the same sequential order. The symptoms of Gridhrasi
are Ruk, Toda, Spandana and Stambha. In
modern view the above condition is described as pain or paresthesia which is
experienced along the course and distribution of the sciatic nerve or an associated
lumbosacral nerve root. It is well known
even among the laymen as “Sciaticaâ€. Lifetime incidence of sciatica reported
between 10% to 40% with an annual incidence of 1% to 5% of the population. The prevalence
of sciatica varies considerably ranging from1.6% in the general population to
43% in the working population.
The change in lifestyle including
busy professional and social life, improper sitting posture in offices,
factories, overexertion, jerking movements during travelling and sports– are
few factors creating undue pressure to the spine. Also, other factors like irregular & improper food habits,
suppression of natural urges, lack of proper sleep or sleeping during day time
and over exerting day to day work has led to an increased incidence of low
backache and sciatica. Likewise, progressive disorders affecting the pelvis and
nearer structures are also precipitating this condition. In this way, this
disease is now becoming a significant threat to the working population.
In reference to sciatica treatment, contemporary
medical science has only symptomatic management with analgesics and
anti-inflammatory drugs which causes serious side effects on prolonged usage.
In some cases, if nerve compression is more, then steroid injections,
peri-radicular infiltration and surgical interventions like laminectomy,
discectomy are indicated but these procedures are expensive with their own
limitations. All these factors show a gravity of the disease and have compelled
to go for a better remedial search or alternate choice of treatment which can
be achieved through Ayurveda.
In Ayurveda, Basti Chikitsa is
considered as the most effective form of treatment in the management of various
ailments especially in diseases occurring due to Vata Dosha due to its multi- dimensional
action. Acharya Charaka and Acharya Vagbhata have described Basti
as Ardha Chikitsa which itself is self-explanatory about its
importance. It is also considered as one among the
important treatment procedures in Gridhrasi.
There are different patterns of Basti explained in our classics
like Yoga Basti, Kala Basti and Karma Basti , but Acharya Kashyapa has mentioned special pattern
for Kala Basti where,
12 Anuvasana Basti’s and 3 Niruha Basti’s are mentioned
which would be more beneficial in Vataja Rogas including Gridhrasi.
Considering the above factors, an attempt has been made to clinically
evaluate the comparative efficacy of Kashyapokta Kala Basti and Vagbhatokta
Kala Basti in Vataja Gridhrasi (Sciatica) |