| CTRI Number |
CTRI/2025/08/092343 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Detailed study on veins of lower limb with its effect of siravedh in padadari or crack in heel |
|
Scientific Title of Study
|
Exploratory Study on Sakthigata Sira & effect of Siravedh in Padadari |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ramesh kumar |
| Designation |
MD scholar |
| Affiliation |
Post graduate institute of ayurveda |
| Address |
Room number14B department of shalya tantra sanjeevani hospital Post graduate institute of ayurveda DSSRAU karwar nagaur road jodhpur
Room number14B department of shalya tantra sanjeevani hospital Post graduate institute of ayurveda DSSRAU karwar nagaur road jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9784455930 |
| Fax |
|
| Email |
rbudania07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ramesh kumar |
| Designation |
MD scholar |
| Affiliation |
Post graduate institute of ayurveda |
| Address |
Room number14B department of shalya tantra sanjeevani hospital Post graduate institute of ayurveda DSSRAU karwar nagaur road jodhpur
Room number14B department of shalya tantra sanjeevani hospital Post graduate institute of ayurveda DSSRAU karwar nagaur road jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9784455930 |
| Fax |
|
| Email |
rbudania07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr shyoram sharma |
| Designation |
Associate professor |
| Affiliation |
Post graduate institute of ayurveda |
| Address |
Room number14B department of shalya tantra sanjeevani hospital Post graduate institute of ayurveda DSSRAU karwar nagaur road jodhpur
Room number14B department of shalya tantra sanjeevani hospital Post graduate institute of ayurveda DSSRAU karwar nagaur road jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9460724766 |
| Fax |
|
| Email |
shyoramsharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post graduate institute of ayurveda DSRRAU Jodhpur Rajasthan India 342037 |
|
|
Primary Sponsor
|
| Name |
Post graduate institute of ayurveda DSRRAU jodhpur |
| Address |
Department of Rachana sharir Post graduate institute of ayurveda karwar jodhpur rajasthan |
| 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 |
| Dr shyoram sharma |
Sanjeevani hospital |
Room number14B department of shalya tantra sanjeevani hospital Post graduate institute of ayurveda DSSRAU karwar nagaur road jodhpur Rajasthan India 342037
Jodhpur
RAJASTHAN |
9460724766
shyoramsharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr sarvepalli radhakrishnan ayurveda university jodhpur post graduate institute of ayurveda institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: PADADARI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | sirAvedhaH, सिरावेधः | (Procedure Reference: sushurut sharir 8/16, Procedure details: The patient will be made to sit comfortably on the examination table with legs suspended & feet supported on the step of the table. A tourniquet will be tied around the mid-calf region to make the veins more prominent. A centrally situated prominent vein from the dorsal venous arch, approximately 2 Angul above the Padagata Kshipra Marma will be selected. The region will then be properly cleaned & sterilized with a spirit swab. A hypodermic needle will be inserted into the vein & blood will be allowed to flow into a kidney tray. Bloodletting will continue until it stops on its own, with approximately 20ml of blood being let out per sitting.)
|
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient 25 to 50 years irrespective of age and sex.
2 Willing to give written well informed consent.
|
|
| ExclusionCriteria |
| Details |
Patients having Anemia, malabsorption syndrome ,Hepatitis ,Psoriasis, Bala , Sthavira , Ruksha Kshatakshina ,Krisha, Garbhini ,,Akshepaka Vata Pakshaghata. Those who observe Upavasa and those who are afflicted with Pipasa and Murccha and patients having other serious systemic disease. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the symptomatic relief in padadari by sakhtigata siravedha |
45days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
08/09/2025 |
| 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="9"
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
|
This is an open label single arm trial to evaluate the effect of Sakthigata Siravedhan in Paddari. The patient will be made to sit comfortably on the examination table with legs suspended and feet supported on the step of the table. A tourniquet will be tied around the mid-calf region to make the veins more prominent. A centrally situated prominent vein from the dorsal venous arch, approximately 2 Angula above the Padagata Kshipra Marma will be selected. The region will then be properly cleaned and sterilized with a spirit swab. A hypodermic needle will be inserted into the vein, and blood will be allowed to flow into a kidney tray. Bloodletting will continue until it stops on its own, with approximately 20ml of blood being let out per sitting.
After the blood stops flowing, the needle will be removed. The insertion site will then be cleaned with a spirit swab, and a sterile band-aid will be applied. All the vitals of the patient will be noted, and they will be within normal limits. The patient will be kept under observation in the hospital for 2 hours to monitor for any adverse effects. In total, 3 sittings of Siravedha will be administered with a gap of 9 days . |