| CTRI Number |
CTRI/2022/07/044073 [Registered on: 18/07/2022] Trial Registered Prospectively |
| Last Modified On: |
15/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of madhukadi yoga and hriveradi vati in threatened abortion along with survey study |
|
Scientific Title of Study
|
Role of madhukadi yoga and hriveradi vati in the management of garbhsrava along with survey study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr seema shukla |
| Designation |
Head of department, prasuti tantra evum stree roga |
| Affiliation |
RGGPG ayurvedic college and hospital |
| Address |
RGGPG ayurvedic college and hospital, paprola, kangra
Rajiv gandhi ayurvedic college and hospital, paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418008833 |
| Fax |
|
| Email |
drseemanil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr seema shukla |
| Designation |
Head of department, prasuti tantra evum stree roga |
| Affiliation |
RGGPG ayurvedic college and hospital |
| Address |
RGGPG ayurvedic College and hospital, paprola, kangra
Rajiv gandhi ayurvedic college and hospital, paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418008833 |
| Fax |
|
| Email |
drseemanil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pratibha mehra |
| Designation |
PG scholar, prasuti tantra evum stree roga |
| Affiliation |
RGGPG ayurvedic college and hospital |
| Address |
RGGPG ayurvedic college and hospital, paprola, kangra
Rajiv Gandhi ayurvedic college and hospital, paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418991327 |
| Fax |
|
| Email |
pratibhamehra48@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak pharmacy, RGGPG ayurvedic college and hospital paprola, district kangra, H.P.
Research institute in ISM jogindernagar, district mandi, H.P. |
|
|
Primary Sponsor
|
| Name |
Principal |
| Address |
RGGPG ayurvedic college and hospital paprola kangra, HP |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| HOD department of prasuti tantra evum stree roga |
RGGPG ayurvedic college and hospital paprola kangra H.P |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr seema shukla |
RGGPG ayurvedic college and hospital |
OPD and IPD of department of prasuti tantra evum stree roga, RGGPG ayurvedic college and hospital paprola
Kangra
HIMACHAL PRADESH |
9418008833
drseemanil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee (human) RGGPG ayurvedic College and hospital paprola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O200||Threatened abortion, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Natural micronised progesterone | 200 mg natural micronised progesterone oral tablet twice daily during 2 months of trial period | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Madhukadi yoga, Reference: sushruta samhita shareera sthana 10/63-69, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -milk), Additional Information: -1-2gm of madhukadi yoga orally twice daily will be given to 15 patients during 2 months trial period | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Hriveradi vati, Reference: yogaratnakara stree roga chikitsa 9, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -water), Additional Information: -250mg hariveradi vati orally twice daily will be given to 15 patients during 2 months trial period |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
i) patients ready for the trial after written consent
ii)married female patients of age group between 20-35 years
iii)patient with confirmed pregnancy
iv)patient with gestational age upto 20weeks
V)patient presenting with the sign and symptoms of Threatened abortion |
|
| ExclusionCriteria |
| Details |
i) patients not willing for trial and consent
ii) unmarried women
iii)Gynaecological problems-cervical ectopy,polyp or carcinoma associated with pregnancy
iv) blighted ovum, missed/inevitable/septic abortion, ectopic pregnancy,molar pregnancy
v)any other serious illness as malignancy,HTN, diabetes mellitus associated with pregnancy
vi)ICTC, VDRL, HBsAg positive patient |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Overall improvement which will be shown by the patients in sign and symptoms |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Overall improvement which will be shown by the patients in sign and symptoms |
1 month |
|
|
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)
|
20/07/2022 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Research Report will be soon published after the completion of trial. 30 patients fulfilling the inclusion and exclusion criterias will be randomly selected from the OPD and IPD of Department of Prasuti Tantra evum Stree Roga, RGGPG Ayurvedic College and Hospital, Paprola. Patients will be divided randomly into 2 groups; Group I and Group II each with 15 patients. Group I will be given oral preparation of Madhukadi Yoga and Hariveradi vati while Group II will be given Oral preparation of natural micronised progesterone. Result will be assessed on the basis of subjective and objective assessment criterias. |