| CTRI Number |
CTRI/2024/05/067105 [Registered on: 09/05/2024] Trial Registered Prospectively |
| Last Modified On: |
08/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Raktmokshana and Agni Karma after Virevhan Karma in the managament of Sciatica. |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the effect of Raktmokshana and Agni Karma after Virevhan Karma in the managament of Gridhrasi w.s.r to 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 |
Prof Pushpinder Singh |
| Designation |
Professor |
| Affiliation |
Rajiv Gandhi Government Postgraduate Ayurvedic College and Hospital Paprola |
| Address |
Room No.203 PG Department of Panchkarma RGGPG Ayu College
and Hospital Paprola Tehsil Baijnath District Kangra HP
Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418049421 |
| Fax |
|
| Email |
drpushpinderpk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Pushpinder Singh |
| Designation |
Professor |
| Affiliation |
Rajiv Gandhi Government Postgraduate Ayurvedic College and Hospital Paprola |
| Address |
Room No.203 PG Department of Panchkarma RGGPG Ayu College
and Hospital Paprola Tehsil Baijnath District Kangra HP
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418049421 |
| Fax |
|
| Email |
drpushpinderpk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Santosh kumar |
| Designation |
PG Scholar |
| Affiliation |
Rajiv Gandhi Government Postgraduate Ayurvedic College and Hospital Paprola |
| Address |
Room No.203 PG Department of Panchkarma RGGPG Ayu College
and Hospital Paprola Tehsil Baijnath District Kangra HP
Kangra
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8219933918 |
| Fax |
|
| Email |
santoshdadhwal1985@gmail.com |
|
|
Source of Monetary or Material Support
|
| Baijnath Pharmacy Paprola Distt Kangra HP |
| Charak Pharmacy Rajiv Gandhi Government postgraduate Ayurvedic College and Hospital
Paprola District Kangra HP |
| Research Institute in ISM Jogindarnagar District Mandi HP |
|
|
Primary Sponsor
|
| Name |
Prof Vijay Chaudhary |
| Address |
Principal cum Dean Room No.105 Admin Block Rajiv Gandhi
Government Postgraduate Ayurvedic College and Hospital Paprola
District Kangra HP 176115 India |
| Type of Sponsor |
Other [] |
|
|
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 |
| Prof Pushpinder Singh |
Rajiv Gandhi Government Postgraduate Ayurvedic College and Hospital Paprola |
Room No.703 PG Department of Panchkarma RGGPG Ayu College
and Hospital Paprola Tehsil Baijnath District Kangra HP
Kangra
HIMACHAL PRADESH
176115
Kangra
HIMACHAL PRADESH |
09418049421
drpushpinderpk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Human) Rajiv Gandhi Government Postgraduate Ayurvedic College and Hospital Paprola District Kangra HP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M959||Acquired deformity of musculoskeletal system, unspecified. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Ch.Chi.28/101, Procedure details: Agnikarma is done after Virechana.)
| | 2 | 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: Ch.Chi.28/101, Procedure details: Raktmokshan is done after Virechana.)
|
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient willing for study and are ready to give their consent.
2.Patient between the age group of 25-70 yrs.
3.Patient presenting with cardinal features of Gridhrasi (Sciatica).
4.Patient fit for Virechana Karma, Raktamokshana and Agni Karma. |
|
| ExclusionCriteria |
| Details |
1.Patients not willing for the study and do not want to give their consent.
2.Patients below age of 25 years and above 70 years of age.
3.Patient not fit for Virechana Karma, Raktamokshana and Agni Karma.
4.Patients suffering from any infectious disease, bleeding disorders anemia diabetes mellitus etc.
5.Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of Raktamokshana and Agni Karma after Virechana Karma in the management of Gridhrasi will be known. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Development of effective Ayurvedic treatment for Gridhrasi. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
20/05/2024 |
| 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="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
|
In Ayurvedic literature Ghridhrasi has been described in details in Charaka, Shusruta and Vagbhatta Samhitas along with its management. "Ghridhrasi" is one of the Shool pradhan clinical entity mentioned among eighty types of Nanatmaj vaat vyadhis.(Ch.Su.20/11 )
Acharya Charaka has indicated Snehan Svedan mridu virechan, rakat mokshan bastis and agnikarma in the management of Gridhrasi in Chikitsa Sthan 28 Keeping in mind to develop effective Ayurvedic treatment protocol for the condition, the present study “To evaluate The Effect of Raktamokshana and Agni Karma after Virechana in the management of Gridhrasi w.s.r.to Sciatica †has been selected. |