| CTRI Number |
CTRI/2025/10/096200 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
17/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of blood letting therapy in sciatica(A conventional approach to pain relief) |
|
Scientific Title of Study
|
Clinico-Anatomical Study of Sira Sharir and Therapeutic Evaluation of Siravedha in management of Giradhrasi(Sciatica) |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Komal Sharma |
| Designation |
PhD Scholar |
| Affiliation |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University,Jodhpur |
| Address |
Rachana Sharir Department M.M.M.Goverment Ayurved College Campus Hospital
Udaipur
RAJASTHAN
313001
India |
| Phone |
9636707186 |
| Fax |
|
| Email |
drkomalsharma079@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Kumar Sharma |
| Designation |
Associate Professor |
| Affiliation |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University,Jodhpur |
| Address |
Deparment of Rachana Sharir,Post Graduate Institute of Ayurveda And Research, Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9166216760 |
| Fax |
|
| Email |
rksharma69jumbo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Komal Sharma |
| Designation |
PhD Scholar |
| Affiliation |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University,Jodhpur |
| Address |
Room no.24
M.M.M.Goverment Ayurved College Campus Hospital
Udaipur
RAJASTHAN
313001
India |
| Phone |
9636707186 |
| Fax |
|
| Email |
drkomalsharma079@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurveda and Research DSRRAU, Jodhpur,Rajasthan India Pin Code-342037 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurveda and Research DSRRAU Jodhpur |
| Address |
Post Graduate Institute of Ayurveda and Research DSRRAU, Jodhpur,Rajasthan-342037 |
| Type of Sponsor |
Other [Goverment Ayurved Medical collge] |
|
|
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 Komal Sharma |
Government AyurvedHospital |
Room no.3, Kayachikitsa & Panchkarma Department
M.M.M.Goverment Ayurved College Campus Hospital
Udaipur
RAJASTHAN |
09636707186
drkomalsharma079@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Post Graduate Institute Of Ayurved Institutional Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M541||Radiculopathy. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | sirAvedhaH, सिरावेधः | (Procedure Reference: From Charaka Samhita, Procedure details: Blood letting will be done from the location as specified in charaka samhita.Amount of blood can be 25ml to 50 ml in sciatica patients.This will done on every 15th day upto 45 days(maximum duation) )
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having symptoms of Gridhrasi (Sciatica) according to Ayurvedic classics as well as modern science.
2.Patients irrespective of sex, religion, occupation will be selected for study.
3.Patient who is willing to take Siravydha Chikitsa.
4.Patients fit for Siravyadha & willing to give written informed consent.
|
|
| ExclusionCriteria |
| Details |
1 Patients below the age of 20 years and above the age of 60 years.
2 Patients with co-morbidities/major illness like DM, HTN, Cardiac diseases, TB spine & bones etc
3 Patients with haematological/bleeding disorders, Ca of lumbosacral plexus, Ca of Cauda equine etc.
4 Patients who are contraindicated for Siravedha.
5 Pregnancy.
6 Use of other alternative medication during Ayurvedic treatment
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in signs and symptoms of Gridhrasi like Ruk (PAIN),Stambha(Stiffness),Suptata (Numbness)Toda (Pricking Pain) as specified in ayurvedic and modern text |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in the quality of life & wellbeing.
|
3 months |
|
|
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 3 |
|
Date of First Enrollment (India)
|
10/12/2025 |
| 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="0"
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
|
Gridhrasi is one of 80 Nanatmaja
Vata vyadhis explained in Ayurveda classics. The name
itself indicates the change of gait shown by the patients because of extreme
pain just like Gridhra -Vulture. This disease not only
inflicts pain but also causes difficulty in walking, which is incredibly
frustrating to the patient.In modern litrature, it is considered Sciatica which
shows the same symptoms as Gridhrasi. Sciatica, a condition of
leg pain, along with tingling, numbness or weakness of leg that originates in
the lower back & travels through the buttock & down the large sciatic
nerve in the back of each leg. Nerve roots compressed in this case mostly are
L4 – L5 & S1- S3.One of the satisfactory answers for Gridhrasi was
given by Siravedha, which was mentioned by numerous Acharyas,
including Charaka, Sushruta, Vagbhatta, Chakradatta,
and Yogratnakara with various sites for Siravedha. However, there is a lack of
comprehensive scientific research on the efficacy of Raktamokshana therapy,
especially Siravedha for Gridhrasi (Sciatica).
A clinico-anatomical study is crucial to bridge this knowledge- gap and provide
evidence-based insights into the effectiveness of Siravedha as a
treatment modality. This research will inform clinical decision-making and
contribute to the development of targeted and effective treatment
strategies.This study will include 60 patients of Gridhrasi .This
will be a nonrandomized single arm trial. Selection will be carried
out according to relevant history, sign, symptoms including laboratory
investigations and the patients giving written informed consent to participate
in the clinical trial. Minimum
two sittings of Siravyadha will be conducted on all
patients during study. Observations will be recorded on 1st day Before
treatment, on 16th day, 31st and on 45th day
after treatment. Amount of blood letting will be 20-50ml. Location will be
medial side of ankle joint as described in charka samhita. Poorva and pashchat
karma will also applicable accordingly. Total duration of treatment can be up
to 45 days. |