| CTRI Number |
CTRI/2021/07/035152 [Registered on: 27/07/2021] Trial Registered Prospectively |
| Last Modified On: |
14/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment of worm Infection Through Ayurvedic Drug |
|
Scientific Title of Study
|
AN ETIOPATHOLOGICAL STUDY OF KAPHAJA KRIMI wsr TO WORM INFESTATION & ITS UPSHAYATAMAKA PARIKSHANA WITH SHIGRUADI MODAK |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Poonam Rawat |
| Designation |
M.D. Scholar |
| Affiliation |
Sampuranand Sanskrit University |
| Address |
Dept. of P.G. Studies in Roga Nidana Evam Vikriti Vijnana,
Govt. P.G. Ayurveda College and Hospital, Varanasi.
Varanasi
UTTAR PRADESH
221001
India |
| Phone |
8318071188 |
| Fax |
|
| Email |
poorawat14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Avadhesh Kumar |
| Designation |
Associate Professor and H O D |
| Affiliation |
Sampurnanand Sanskrit University |
| Address |
Dept. of P.G. Studies in Roga Nidana Evam Vikriti Vijnana,
Govt. P.G. Ayurveda College and Hospital, Varanasi.
Varanasi
UTTAR PRADESH
221001
India |
| Phone |
9455262663 |
| Fax |
|
| Email |
dravadheshsaroj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Poonam Rawat |
| Designation |
M.D. Scholar |
| Affiliation |
Sampurnanand Sanskrit University |
| Address |
Dept. of P.G. Studies in Roga Nidana Evam Vikriti Vijnana,
Govt. P.G. Ayurveda College and Hospital, Varanasi.
Varanasi
UTTAR PRADESH
221001
India |
| Phone |
8318071188 |
| Fax |
|
| Email |
poorawat14@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT PG AYURVEDA COLLEGE AND HOSPITAL, VARANASI |
|
|
Primary Sponsor
|
| Name |
Government PG Ayurvedic College and Hospital |
| Address |
Government PG Ayurvedic College and Hospital Varanasi
|
| 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 |
| Poonam Rawat |
Government PG Ayurveda College and Hospital |
Room no 19 Academic Block Department of Roga Nidana Government PG Ayurveda College and Hospital
Varanasi
UTTAR PRADESH |
8318071188
poorawat14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Post Graduate Ayurvedic College & Hospital Sampurnanand Sanskrit University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A00-A09||Intestinal infectious diseases, (2) ICD-10 Condition:A079||Protozoal intestinal disease, unspecified. Ayurveda Condition: ANNAVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Shigruadi Modak |
Route - orally
Dosage - 12 gm at interval of two days gap i.e.[1st ;4th;7th;10th day] in adult and half of the above dosage in children for 15 days with Mridwikayukta Dugdha |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age: Children ( 5yr to 16yr )
Adult ( 17yr to 70yr )
Sex: both male and female.
Patient with signs and symptom of Kaphaja krimi.
|
|
| ExclusionCriteria |
| Details |
Patient associated with systemic disorders like hypertension, DM,
kidney disorders and with any malignancy.
Pregnant women.
Patient above 70 years of age.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in Signs and Symptoms of krimi roga like panduta [anemia], jwara[fever], shoth[swelling] etc |
After 15 days patient will get relief from all signs and symptoms of worm infection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No recurrence in signs and symptoms of worm infestation. |
7 DAYS and 15 DAYS |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
02/08/2021 |
| 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="1"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Shigruadi modak is a self prepared [swakalpit yoga] drug whose main content is shigru [Moringa Pterygosperma] which is a krimighna drug mentioned in Charak Samhita Sutrasthana - 4. Its main mode of action is tikshn, katu, kapha-vata nashak which would act against the proliferative medium for worm/krimi. The anupaana given would act as anulomaka as well as mridu-virechaka. The base used to prepare this drug would aggravate the hidden krimi and would bring them to the koshtha so that they could be easily excreted out. A minimum of 60 patients suffering from kaphaja krimi will be taken and a special proforma will be made with details of history taking, physical signs and symptoms as mentioned in our classics and allied science.
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