| CTRI Number |
CTRI/2022/06/043416 [Registered on: 22/06/2022] Trial Registered Prospectively |
| Last Modified On: |
21/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Bloodletting and Raasna Guggulu in Treatment of Sciatica |
|
Scientific Title of Study
|
A Comparative Clinical Study of Raasna Guggulu and Raktamokshana along with Raasna Guggulu in Gridhrasi (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 Ajay Kumar Gupta |
| Designation |
Professor |
| Affiliation |
Rishikul Campus, Rishikul Campus, Haridwar, Uttarakhand Ayurved University |
| Address |
OPD No. 7, Department of Shalya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9412856414 |
| Fax |
|
| Email |
akg1409@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Kumar Gupta |
| Designation |
Professor |
| Affiliation |
Rishikul Campus, Rishikul Campus, Haridwar, Uttarakhand Ayurved University |
| Address |
OPD No. 7, Department of Shalya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9412856414 |
| Fax |
|
| Email |
akg1409@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gopal Singh |
| Designation |
PG Scholar |
| Affiliation |
Rishikul Campus, Haridwar, Uttarakhand Ayurved University |
| Address |
OPD No. 7, Department of Shalya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University
Hardwar
UTTARANCHAL
249401
India |
| Phone |
7982942162 |
| Fax |
|
| Email |
5517Gopal07@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD No.7, Department of Shalya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University |
|
|
Primary Sponsor
|
| Name |
Uttarakhand Ayurved University |
| Address |
Uttarakhand Ayurved University, Harrawala, Dehradun |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Gopal Singh |
Rishikul Campus, Haridwar |
OPD No. 7, Department of Shalya Tantra, Rishikul Campus, Haridwar, Uttarakhand Ayurved University
Hardwar
UTTARANCHAL |
7982942162
5517Gopal07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Uttarakhand Ayurved University, Rishikul Campus, Haridwar |
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: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | raktamokShaNam/ SoNitasrAvaH/ asravisrutiH/ SastravisrAvaNam, रकà¥à¤¤à¤®à¥‹à¤•à¥à¤·à¤£à¤®à¥/ शोणितसà¥à¤°à¤¾à¤µà¤ƒ/ असà¥à¤°à¤µà¤¿à¤¸à¥à¤°à¥à¤¤à¤¿à¤ƒ/शसà¥à¤¤à¥à¤°à | (Procedure Reference: Bhel Samhita chikitsa 25/45, Procedure details: 1. Before commencing the procedure, written informed consent will be taken.
2. Then Patient will be asked to lie down in prone position and region with maximum tenderness of affected leg will be selected and disinfected with antiseptic solution.
3. Then the Shringa Yantra will be applied on the selected area of skin and a mild negative pressure will be created inside using the manual pump.
4. This will cause mild elevation of the skin inside the Shringa Yantra, which will be maintained for )
(1) Medicine Name: Raasna Guggulu, Reference: Chakradutta Vatavyadhi 50, Route: Oral, Dosage Form: Guggulu, Dose: 1(g), Frequency: bd, Duration: 28 Days | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Raasna Guggulu, Reference: Cakradatta Vatavyadhi, Route: Oral, Dosage Form: Guggulu , Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: luke warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient who have classical sign and symptoms of Gridhrasi
Willingness of patients for study |
|
| ExclusionCriteria |
| Details |
Pandu (Anaemic, Hb < 10 gm%)
Garbhini (Pregnancy)
Shosha (Tuberculosis)
Diabetes Mellitus
Uncontrolled Hypertension
Malignancy of spine or other organs
History with spine fracture (trauma)
Cardiac diseases
HIV positive
Hepatitis A,B,C positive
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Outcome will be measured with the parameters -
1. Ruka (Pain/Discomfort) in lower back and lower limbs
2. Stambha (Stiffness) in lower back and lower limbs
3. Aruchi (dislike / aversion of food)
4. Spandana (Throbbing / Pulsating) in lower back and lower limbs
5. Gaurava (Heaviness / Lassitude)in lower back and lower limbs |
Total 3 sittings of Raktamokshana on 14 days interval for 28 days
2gm of Raasna Guggulu (2 tablets of 500mg each twice a day) for 28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in angle of SLR test |
Total 3 sittings of Raktamokshana on 14 days interval for 28 days
2gm of Raasna Guggulu (2 tablets of 500mg each twice a day) for 28 days |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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
|
N/A |
|
Date of First Enrollment (India)
|
26/06/2022 |
| 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="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Gridhrasi is described as one
of Vatavyadhi and included under 80 types of Nanatmaja Vatavyadhi
described by Acharya Charaka. It is characterized by the onset of Ruka
(pain), Toda (pricking pain), Stambha (stiffness), Spandana (pulsation)
initially in Sphika (buttock) and then radiating distally to posterior
aspect of Kati (waist), Pristha (back), Uru (thigh), Janu
(knee), Jangha (calf) up to Pada (foot). On the basis of symptoms of Gridhrasi, it
can be equated with Sciatica in modern science.Many
formulations and procedures have been given by Acharyas in the treatment
of Gridhrasi (Sciatica) among them Raasna
guggulu and Raktamokshana has been selected for the study. As in Gridhrasi
(Sciatica) mainly Vata dosha is
vitiated,
Raasna and Guggulu are among best drugs for vitiated Vata dosha by Acharya Charaka and Acharya Vagbhatta respectively.
Thus, Raasna guggulu can be a good therapeutic option. Moreover, as Snayu
and Rakta dhatu are involved in Gridhrasi (Sciatica), so Raktamokshana
can also be an efficient therapeutic option in this disease. Among various
methods of Raktamokshana, Shringa Yantra is one of the potent
instruments described by Acharya
Sushruta for the pacification
of vitiated Vata dosha.
AIM
To
compare the effect of Raasna
guggulu (orally)
alone and Raktamokshana by modified Shringa Yantra along with Raasna guggulu (orally) in the management of Gridhrasi
(Sciatica).
OBJECTIVES
1.
To evaluate the effect of Raktamokshana
by modified Shringa Yantra along with Raasna guggulu in management
of Gridhrasi (Sciatica).
2.
To evaluate the clinical
efficacy of Raasna guggulu
alone in management of Gridhrasi (Sciatica).
3.
To provide a cost effective and safe
treatment for the patients of Gridhrasi (Sciatica).
4.
To explore the literature regarding Raktamokshana
and Gridhrasi (Sciatica)
in
Ayurvedic and modern text.
|