| CTRI Number |
CTRI/2024/07/071494 [Registered on: 29/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Curative] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study on comparing two herbal medicines(Sahacharadi Kashaya and Meshashrungyadi Kashaya) with blood letting therapy for managing Sciatica(Gridhrasi) |
|
Scientific Title of Study
|
An open label randomized comparative clinical study to evaluate the efficacy of Sahacharadi Kashaya and Meshashrungyadi Kashaya with Siravyadha in the management of 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 Rachana A J |
| Designation |
PG Scholar |
| Affiliation |
JSS Ayurveda Medical College and Hospital |
| Address |
Department of Kayachikitsa OPD no 1
JSS Ayurveda Medical College and Hospital
41 E Lalithadripura Road Alanahalli Mysuru
Mysore
KARNATAKA
570028
India |
| Phone |
9108679803 |
| Fax |
|
| Email |
rachurachu773@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh A Udapudi |
| Designation |
Professor and HOD |
| Affiliation |
JSS Ayurveda Medical College and Hospital |
| Address |
Department of Kayachikitsa OPD no 1
JSS Ayurveda Medical College and Hospital
41 E Lalithadripura Road Alanahalli Mysuru
Mysore
KARNATAKA
570028
India |
| Phone |
9844136277 |
| Fax |
|
| Email |
drrajeshudapudi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rachana A J |
| Designation |
PG Scholar |
| Affiliation |
JSS Ayurveda Medical College and Hospital |
| Address |
Department of Kayachikitsa OPD no 1
JSS Ayurveda Medical College and Hospital
41 E Lalithadripura Road Alanahalli Mysuru
Mysore
KARNATAKA
570028
India |
| Phone |
9108679803 |
| Fax |
|
| Email |
rachurachu773@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ingredients of Meshashrungyadi Kashaya will be obtained from authentic sources and will be prepared at Arya Vaidya Sala Kottakkal Pharmacy Kerala India
Sahacharadi Kashaya will be procured from GMP certified pharmacy |
|
|
Primary Sponsor
|
| Name |
Dr Rachana A J |
| Address |
Department of Kayachikitsa OPD no 1
JSS Ayurveda Medical College and Hospital
41 E Lalithadripura Road Alanahalli Mysuru |
| 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 Rachana A J |
JSS Ayurveda Medical College and Hospital |
Department of Kayachikitsa OPD no 1 and IPD
41 E Lalithadripura Road
Alanahalli Mysuru
Mysore
KARNATAKA |
9108679803
rachurachu773@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Clearance committee Human, JSS Ayurveda Medical College Mysuru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M469||Unspecified inflammatory spondylopathy. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Meshashrungyadi Kashaya, Reference: Vangasena Samhitha Vatavyadhi Adhyaya, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Sukhoshna Jala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Sahacharadi Kashaya, Reference: Ashtanga Hridaya Vatavyadhi Chikitsa Adhyaya, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Sukhoshna Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects irrespective of gender between the age group of 25 to 65 years will be selected.
Subjects with Classical Signs and Symptoms of Gridhrasi vis-Ã -vis Sciatica will be included.
Freshly detected and previously diagnosed cases of Gridhrasi vis-Ã -vis Sciatica will be included in the study.
Subjects willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Previously diagnosed case of active systemic Carcinoma and Neoplastic conditions of the Spinal cord.
Diagnosed case of fracture (lesser than 6months) of the Spine.
Diagnosed case of Infective conditions of the Spine.
Previously diagnosed case of Cardiac illness and subjects on Thrombolytic drugs.
Previously diagnosed case of any systemic illness which interfere with the intervention.
Subjects having Abnormal Range of Clotting time and Bleeding time.
Pregnant Women and Lactating Mothers.
Subjects not fit for Siravyadha. |
|
|
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 |
| To asses the effect of Siravyadha with Sahacharadi Kashaya and Meshashrungyadi Kashaya for the pain management as per the VAS Scoring |
base line 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To Evaluate the Combined Effect of Sahacharadi Kashaya and Siravyadha in the Management of Gridhrasi vis-Ã -vis Sciatica.
To Evaluate the Combined Effect of Meshashrungyadi Kashaya and Siravyadha in the Management of Gridhrasi vis-Ã -vis Sciatica. |
1 day after Siravyadha
15 days after Shamanoushadhi
30th day after treatment protocol |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
10/08/2024 |
| 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 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
|
Gridhrasi is one among the Vataja Nanatmaja Vikaras which is most commonly encountered in the day-to-day clinical practice. Back pain has been a very common symptom which interferes with the functional ability of the lower back and lower limbs. It may be unilateral or bilateral, particularly seen in most of the people in their active period of life causing difficulty in performing their routine activities. It is mainly of two types Vataja and Vatakaphaja, having Vataja Lakshanas like Ruk, Toda, Sthamba, Spandana in Sphik, Kati, Uru, Janu, Jangha, Paada and Kaphaja Lakshanas like Tandra, Gourava, Arochaka. In contemporary medicine, 90% of the patients having Sciatica recover with conservative line of treatment with analgesia as it is concerned about the pain management and early mobilization. Long term usage of analgesics and NSAID’s may lead to systemic complications and Surgical intervention would not give permanent relief. Hence and effort is made to find out and alternative treatment in Ayurveda to benefit the patient having Gridhrasi. Siravyadha has been mentioned as the first line of treatment in the Chikitsa Sutra of Gridhrasi in Charaka Chikitsa Sthana and Sushrutha opines that the diseases which are not cured by Sneha, Lepa etc., are instantaneously cured by Siravyadha. Meshashrungyadi Kashaya and Sahacharadi Kashaya are mentioned in Vangasena Samhita Vatavyadhi Adhyaya and Ashtanga Hridaya Vatavyadhi Chikitsa Adhyaya respectively bearing Phalashruthi which has Rujahara Karma. Hence the intended study is to compare and evaluate the efficacy of two different Kashayas with Siravyadha in two groups in the management of Gridhrasi. |