| CTRI Number |
CTRI/2022/07/043874 [Registered on: 08/07/2022] Trial Registered Prospectively |
| Last Modified On: |
07/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two Ayurvedic kashaya formulations, Meshashringadi kashaya and Sahacharadi kashaya in patients of Gridhrasi(Sciatica). |
|
Scientific Title of Study
|
A Randomised Controlled Clinical Study to Evaluate the Efficacy of Meshashringadi Kashaya in Gridhrasi W.S.R to Sciatica. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepa |
| Designation |
PG Scholar |
| Affiliation |
Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodbidri Affiliated to RGUHS, Bengaluru |
| Address |
Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodbidri.
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8550801650 |
| Fax |
|
| Email |
dr4deepa2021@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surekha Pai |
| Designation |
MD (Ayurveda) |
| Affiliation |
Alvas Ayurveda Medical College |
| Address |
Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodbidri.
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8921385332 |
| Fax |
|
| Email |
drsurpai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepa |
| Designation |
PG Scholar |
| Affiliation |
Alvas Ayurveda Medical College |
| Address |
Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodbidri.
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8550801650 |
| Fax |
|
| Email |
dr4deepa2021@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodbidri |
|
|
Primary Sponsor
|
| Name |
Dr Deepa |
| Address |
Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodbidri |
| 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 Deepa |
Alvas Ayurveda Medical College and Hospital,Vidyagiri,Moodbidri |
PG studies in the Department of Kayachikitsa, Alvas Ayurveda Medical Hospital, Vidyagiri, Moodbidri
Dakshina Kannada
KARNATAKA |
8550801650
dr4deepa2021@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Clinical Ethics Committee Alvas Ayurveda Medical College, Vidyagiri, Moodbidri, India |
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 | Drug | Classical | | (1) Medicine Name: Sahacharadi Kashaya, Reference: Ashtanga Hrudaya, Vatavyadhi chikitsa in chikitsa sthana 21st Chapter, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Eranda Taila), Additional Information: Eradnda Taila Sahapana 10 drops | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Meshashringadi Kashaya,, Reference: Vangasena Samhita or Chikitsa Sara Sangraha, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Eranda Taila), Additional Information: Eranda Taila Sahapana 10 drops |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with lakshana of Gridhrasi characterized by Radiating pain from sphik and Kati to Prishtha, Uru, Janu, Jangha and Pada along with or without Stambha, Toda, Tandra, Gourava, Aruchi.
2. Positive SLR Test. |
|
| ExclusionCriteria |
| Details |
1. Patients with known case of Neoplastic, Tuberculosis of spine, Epidural abscess, Spinal canal stenosis, Cauda equina syndrome, Sacroilitits.
2. Sciatica associated with Diabetic neuropathy.
3. Patients who have lost the control on bladder and defecation.
4. Pregnant women and Lactating mothers. |
|
|
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 |
| Effects of the treatment will be done based on detailed case proforma, by adopting standard scoring methods of subjective parameters such as Ruk,Toda,Stambha,Tandra,Gourava,Aruchi. |
37days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Objective parameters like SLR test, Time taken to cover the distance of 50 foot. Assessment will be done before,during,after the treatment as well as after the follow uo period of 7 days. |
37days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
11/07/2022 |
| 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="25" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
This study is a randomized, single blind, parallel group, actively controlled clinical study with comparative standard drug - Sahacharadi kashaya and interventional drug - Meshashringadi kashaya with the dosage 25ml ( Total : 50 ml per day) kashaya along with 10 drops of Eranda taila as Sahapana on empty stomach before to the meals as BID. This study is conducting on patients of Gridhrasi/Sciatica belongs to age of 18yrs to 60yrs who gives written and verbal consent for undergoing clinical study. Study will be conducting in Alvas Ayurveda Medical College and Hospital, Vidyagiri, Moodbidri. Interventional period of this study is 30 days. Assessment will be done on base line zero day, 16th day, 31st day, 37th day.
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