| CTRI Number |
CTRI/2023/08/056177 [Registered on: 07/08/2023] Trial Registered Prospectively |
| Last Modified On: |
05/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Trial to study the effect of Meshashringyadi Kashaya and Erandadi Kashaya with Kati Basti in Sciatica. |
|
Scientific Title of Study
|
Effectiveness of Meshashringyadi Kashaya and Erandadi Kashaya with Kati Basti in Gridhrasi - A Comparative Clinical Study |
| 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 Gayathri Goudampally |
| Designation |
Postgraduate Scholar, Department of PG studies in Kayachikitsa |
| Affiliation |
SDMIAH Bengaluru |
| Address |
OPD - 3 of Kayachikitsa, Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Kumbalgodu post, Bengaluru.
Bangalore
KARNATAKA
560074
India |
| Phone |
9535936344 |
| Fax |
|
| Email |
goudampallygayathri@sdmayurbangalore.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priya Bhat |
| Designation |
Associate Professor, Department of Kayachikitsa |
| Affiliation |
SDMIAH Bengaluru |
| Address |
OPD - 3 of Kayachikitsa, Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Kumbalgodu post, Bengaluru.
Bangalore
KARNATAKA
560074
India |
| Phone |
9986451162 |
| Fax |
|
| Email |
dr.priyabhat23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayathri Goudampally |
| Designation |
Postgraduate Scholar, Department of PG studies in Kayachikitsa |
| Affiliation |
SDMIAH Bengaluru |
| Address |
OPD - 3 of Kayachikitsa, Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Kumbalgodu post, Bengaluru.
Bangalore
KARNATAKA
560074
India |
| Phone |
9535936344 |
| Fax |
|
| Email |
goudampallygayathri@sdmayurbangalore.in |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Kumbalgodu post, Bengaluru. |
|
|
Primary Sponsor
|
| Name |
Dr Gayathri Goudampally |
| Address |
Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Kumbalgodu post, Bengaluru. |
| 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 Gayathri Goudampally |
Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Bengaluru |
Out Patient Department of Kayachikitsa and Panchakarma, Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Kumbalgodu post, Bengaluru
Bangalore
KARNATAKA |
9535936344
goudampallygayathri@sdmayurbangalore.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Kumbalgodu post, Bengaluru. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M959||Acquired deformity of musculoskeletal system, unspecified. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | kaTibastiH, कटिबसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Panchakarma Illustrated by Dr. G Srinivasa Acharya, Procedure details: PROCEDURE OF KATI BASTI:
1.Purvakarma:
Step 1: Preparation of subjects:
Patient will be made to lie in prone position.
Step 2: Preparation for the Procedure:
Dough made of Masha flour in the form of rim will be placed over Kati pradesha.
2. Pradhana Karma:
Indirectly heated Taila will be poured inside the rim placed over Kati pradesha with the help of cotton. Uniform
temperature will be maintained throughout the procedure by replacing reheated Taila at regular intervals.
3. Paschat Karm)
(1) Medicine Name: Sahacharadi Taila, Reference: Ashtanga Hrudaya chikitsa sthana, Vata vyadhi chikitsa adhyaya, Route: Topical, Dosage Form: Taila, Dose: 200(ml), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Meshashringyadi Kashaya, Reference: Vangasena Vata vyadhi adhikara, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Eranda taila - 2 ml), Additional Information: - | | 3 | Comparator Arm | Procedure | - | kaTibastiH, कटिबसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Panchakarma Illustrated by Dr. G Srinivasa Acharya, Procedure details: PROCEDURE OF KATI BASTI:
1.Purvakarma:
Step 1: Preparation of subjects:
Patient will be made to lie in prone position.
Step 2: Preparation for the Procedure:
Dough made of Masha flour in the form of rim will be placed over Kati pradesha.
2. Pradhana Karma:
Indirectly heated Taila will be poured inside the rim placed over Kati pradesha with the help of cotton. Uniform
temperature will be maintained throughout the procedure by replacing reheated Taila at regular intervals.
3. Paschat Karm)
(1) Medicine Name: Sahacharadi Taila, Reference: n Ashtanga Hrudaya chikitsa sthana, Vata vyadhi chikitsa adhyaya, Route: Topical, Dosage Form: Taila, Dose: 200(ml), Frequency: od, Duration: 7 Days | | 4 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Erandadi Kashaya , Reference: Bhavaprakasha madhyama khanda, Vata vyadhi adhikara, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Sauvarchala lavana - 2g), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Presence of clinical features of either Vataja or VataKaphaja Gridhrasi such as,
a. Ruja in Sphik, Kati, Prushta, Uru, Janu, Jangha, Pada (pain in lumbar, sacral, thigh, calf muscle up to foot).
b. Stamba (stiffness).
c. Toda (pricking sensation).
d. Suptata (numbness).
e. Aruchi (anorexia) With or without.
f. Gourava(heaviness) With or without.
g. Spandana(twitching) With or without.
h. Tandra(lethargy) With or without
2. Patients with positive straight leg raising sign. |
|
| ExclusionCriteria |
| Details |
1. Neoplastic conditions and infective conditions of Spine.
2. Congenital deformity, Vertebral fractures, Vertebral fusion.
3. Patients with inflammatory conditions of spine like Rheumatoid Arthritis and Discitis.
4. Pregnant women and lactating mothers.
5. Patients with uncontrolled Diabetes and uncontrolled Hypertension |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Ruja in Sphik, Kati, Prushta, Uru, Janu, Jangha, Pada (pain in lumbar, sacral, thigh, calf muscle up to foot).
2. Stamba (stiffness).
3. Toda (pricking sensation).
4. Suptata (numbness).
5. Aruchi (anorexia) With or without.
6. Gourava(heaviness) With or without.
7. Spandana(twitching) With or without.
8. Tandra(lethargy) With or without
3. Oswestry disability assessment questionnaire. |
Day-0, Day-7, Day-30. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Straight Leg Raising test (SLR).
2. Visual analogue scale.
3. Oswestry disability assessment questionnaire. |
Day-0, Day-7, Day-30. |
|
|
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 2 |
|
Date of First Enrollment (India)
|
15/08/2023 |
| 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="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 study is a Open label Comparative Clinical
trial to evaluate the Effectiveness of Meshashringyadi
Kashaya and Erandadi Kashaya with Kati Basti in Gridhrasi. Subjects are allocated
in to study and comparator groups respectively. - Study
group includes 15 subjects Qualifying the Inclusion Criteria of the current study with Oral Administration of Meshashringyadi Kashaya 50 ml BD B/F with
Eranda Taila 2 ml as Anupana for 30 days and Kati Basti with Sahacharadi Taila for
7 days (From Day 1 – Day 7 of the trial
period). Comparator
group includes 15 subjects Qualifying the Inclusion Criteria of the current study with Oral Administration of Erandadi Kashaya 50 ml BD B/F with Sauvarchala
lavana 2g as Anupana for 30 days and Kati Basti with Sahacharadi Taila for 7
days (From Day 1 – Day 7 of the trial
period).
The Primary
Outcome measure will be: 1. Ruja in Sphik, Kati, Prushta, Uru, Janu,
Jangha, Pada (pain in lumbar, sacral, thigh, calf muscle up to foot). 2. Stamba (stiffness). 3. Toda (pricking sensation). 4. Suptata (numbness). 5. Aruchi (anorexia) With or without. 6. Gourava(heaviness) With or without. 7. Spandana(twitching) With or without. 8. Tandra(lethargy) With or without.
Time Points:
Day-0, Day-7, Day-30 The Secondary Outcome measure will be: 1.
Straight Leg Raising test (SLR). 2.
Visual analogue scale. 3.
Oswestry disability assessment
questionnaire.
Time Points:
Day-0, Day-7, Day-30
|