| CTRI Number |
CTRI/2025/03/082211 [Registered on: 12/03/2025] Trial Registered Prospectively |
| Last Modified On: |
03/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Medical Device Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing preparation and effectiveness of Erandamuladi Niruha Basti given in Sciatica done by electrically powered Basti Sammelana Yantra and manual method |
|
Scientific Title of Study
|
A comparative pharmaceutico-analytical and clinical study to evaluate the efficacy of Erandamuladi Niruha Basti prepared by electrically powered Basti Sammelana Yantra and conventional method of Basti Sammelana in Gridrasi w.s.r to 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 Shubha Shree C N |
| Designation |
P.G Scholar |
| Affiliation |
K.V.G Ayurveda Medical College and Hospital |
| Address |
Room no 1,Department of Panchakarma
K.V.G Ayurveda Medical College and Hospital, Ambateadka, Kurunjibhag, Jattipalla, Sullia.
Dakshina Kannada KARNATAKA 574327 India |
| Phone |
7022464147 |
| Fax |
|
| Email |
shubha.cn1@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Smitha Thamban |
| Designation |
Associate Professor |
| Affiliation |
K.V.G Ayurveda Medical College and Hospital |
| Address |
Dr Smitha Thamban
Associate Professor
Room no 1,Department of Panchakarma
K.V.G Ayurveda Medical College and Hospital, Ambateadka, Kurunjibhag, Jattipalla, Sullia.
Dakshina Kannada KARNATAKA 574327 India |
| Phone |
8277402977 |
| Fax |
|
| Email |
smith.thmbn@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Smitha Thamban |
| Designation |
Associate Professor |
| Affiliation |
K.V.G Ayurveda Medical College and Hospital |
| Address |
Dr Smitha Thamban
Associate Professor
Room no 1,Department of Panchakarma
K.V.G Ayurveda Medical College and Hospital, Ambateadka, Kurunjibhag, Jattipalla, Sullia.
Dakshina Kannada KARNATAKA 574327 India |
| Phone |
8277402977 |
| Fax |
|
| Email |
smith.thmbn@gmail.com |
|
|
Source of Monetary or Material Support
|
| KVG Ayurveda Medical College and Hospital, Ambatedka, Kurunjibhag, Sullia-574327, Dakshina Kannada, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Dr Shubha Shree C N |
| Address |
K.V.G Ayurveda Medical College and Hospital, Ambateadka, Kurunjibhag, Jattipalla, Sullia 574327 |
| 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 Shubha Shree C N |
KVG AYURVEDA MEDICAL COLLEGE AND HOSPITAL |
Room no 01, PANCHAKARMA OPD, KVGAMCH, Ambatedka, Kurunjibhag, Sullia 574327 Dakshina Kannada KARNATAKA |
7022464147
shubha.cn1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KVG AYURVEDA MEDICAL COLLEGE INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
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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 | - | yoga-bastiH, योग-बस्तिः | (Procedure Reference: Charaka chikitsa sthana-28/101, Procedure details: Erandamuladi Niruha Basti will be administered in Gridrasi by preparing with Conventional method after organoleptic characteristics assessment.) (1) Medicine Name: Erandamuladi niruha basti, Reference: Charaka Siddhisthana-3/38-42, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 650(ml), Frequency: od, Duration: 3 Days(2) Medicine Name: Sahacharadi taila, Reference: Astanga Hridaya Chikitsasthana-21/67-69, Route: Rectal, Dosage Form: Taila, Dose: 150(ml), Frequency: od, Duration: 5 Days | | 2 | Intervention Arm | Procedure | - | yoga-bastiH, योग-बस्तिः | (Procedure Reference: Charaka Chikitsasthana-28/101, Procedure details: Erandamuladi Niruha Basti will be administered in Gridrasi by preparing in electrically powered Basti Sammelana Yantra after organoleptic characteristics assessment) (1) Medicine Name: Erandamuladi Niruha Basti, Reference: Charaka siddhisthana-3/38-42, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 650(ml), Frequency: od, Duration: 3 Days(2) Medicine Name: Sahacharadi Taila, Reference: Astanga Hridaya Chikitsasthana-21/67-69, Route: Rectal, Dosage Form: Taila, Dose: 150(ml), Frequency: od, Duration: 5 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with classical symptoms of Gridrasi will be selected.
2. Patients fit for Basti Karma.
|
|
| ExclusionCriteria |
| Details |
1. Patients who are contraindicated for Basti Karma according to Ayurvedic classics.
2. Surgical conditions, congenital deformity.
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluating and comparing Pharmaceutico-analysis of Erandamuladi Niruha Basti dravya prepared by electrically powered Basti Sammelana Yantra and conventional method of Basti Sammelana |
2nd day, 4th day and 6th day of Yoga basti |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluating and comparing the efficacy of Erandamuladi Niruha Basti administered in Gridrasi by Electrically powered Basti Sammelana Yantra and by conventional method of Basti Sammelana |
Before treatment(0th day), after treatment(8th day) and on Follow up(24th day) |
|
|
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)
|
18/03/2025 |
| 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 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
|
Revamping Panchakarma therapy is crucial for
global competitiveness. Updated methods and techniques improve treatment
effectiveness, simplify procedures, and standardize practices. This saves time,
manpower, and aids research and clinical refinement.
Basti karma is considered superior to all other therapeutic measures due
to its various actions.
The efficacy of Basti depends on the
ingredients, Sammelana and its
administration. According to Acharya Kashyapa, Samyak Mathita Basti, can only yield benefits.
Sushruta Acharya asserted that
relying solely on the study of a single Shastra
makes it challenging to definitively conclude on concepts. Therefore, he
advocated for the study of multiple Shastras
to attain a more comprehensive understanding. The logic
behind Niruha Basti formulation
should be studied with the help of modern principles like emulsion, collision
system, particle distribution, etc which makes understanding in a better way.
Gridrasi is a condition characterized by intense pain
radiating from lower back to unilateral or bilateral lower limbs, significantly
impairing the functional ability. Gridrasi can be correlated with Sciatica. Sciatica is
characterized by excruciating pain and paraesthesia in the sciatic nerve
distribution or associated lumbosacral nerve root and can severely impact the
quality of life of those affected.
Among various treatment modalities, Basti Karma stands out as a unique procedure recommended for
managing Gridrasi. As Erandamuladi Niruha Basti is indicated
in Vataja Vyadhi associated with Kapha and Sahacharadi Taila in vatavyadhis, we have undertaken these for present
study.
This research study aims to modernize the conventional
approach of Niruha Basti Sammelana. In conventional method, Khalva Yantra is used for Sammelana which makes difficult
to standardize the time, pressure and number of rotation required to mix each
ingredient as these varies from person to person. Moreover, the conventional method is time-consuming
compared to household kitchen blenders used as alternatives. But kitchen
blenders have its own demerits like heat generated during the process may change the temperature of herbal
mixtures and also causes depletion of nutrients and active compounds due to
excessive blending.
To address these
challenges, an electrically powered Basti
Sammelana Yantra was devised, aiming to ensure uniform pressure, speed,
alleviate manual labor, automate the process and enhance
clinical efficacy by integrating modern technology into the conventional method. This study is an attempt to compare the analysis and effectiveness by
administering the Erandamuladi Niruha
Basti prepared with Electrically powered Basti Sammelana Yantra and conventional method. |