| CTRI Number |
CTRI/2021/10/037596 [Registered on: 27/10/2021] Trial Registered Prospectively |
| Last Modified On: |
26/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of Rakta Punarnava Churna in The Management of IUCD Associated Excessive Bleeding. |
|
Scientific Title of Study
|
Open Randomized Clinical Control Trial of Rakta Punarnava Churna in The Management of IUCD Associated Excessive Bleeding. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd TinkuGanesh Khalache |
| Designation |
Associated Professor Prasuti tantra avum stri roga |
| Affiliation |
Annasaheb Dange Ayurved Medical College |
| Address |
Prasuti tantra avum Stri roga department Hon. Shri Annasaheb Dange Ayurveda Medical College and Post Graduate ,Research centre ,Ashta.Tal-walwa Dist-Sangli
Maharashtra
Pin code 416301
Prasuti tantra avum Stri roga department Hon. Shri Annasaheb Dange Ayurveda Medical College and Post Graduate ,Research centreAshta.Tal-walwa Dist-Sangli.
Maharashtra
Pin code 416301
Sangli
MAHARASHTRA
416301
India |
| Phone |
9423041730 |
| Fax |
|
| Email |
tinkuganeshkhalache@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd TinkuGanesh Khalache |
| Designation |
Associated Professor |
| Affiliation |
Annasaheb Dange Ayurved Medical College |
| Address |
Prasuti tantra Avum Stri roga department, Hon. Shri Annasaheb Dange Ayurveda Medical College and Post Graduate ,Research centre Ashta.Tal-walwa Dist-Sangli
Maharashtra,
416301
Prasuti tantra Avum Stri roga department ,Hon. Shri Annasaheb Dange Ayurveda Medical College and Post Graduate ,Research centre Ashta.Tal-walva Dist-Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9423041730 |
| Fax |
|
| Email |
tinkuganeshkhalache@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd TinkuGanesh Khalache |
| Designation |
Associated Professor Prasuti tantra avum stri roga |
| Affiliation |
Annasaheb Dange Ayurved Medical College |
| Address |
Prasuti tantra Avum Stri roga department .Hon. Shri Annasaheb Dange Ayurveda Medical College and Post Graduate ,Research centre Ashta.Tal-walva
Dist-Sangli
Maharashtra
Pin 416301
Prasuti Tantra Avum Stri roga department Hon. Shri Annasaheb Dange Ayurveda Medical College and Post Graduate ,Research centre Ashta.Tal-walwa
Dist-Sangli,
Maharashtra,
Pin 416301
Sangli
MAHARASHTRA
416301
India |
| Phone |
9423041730 |
| Fax |
|
| Email |
tinkuganeshkhalache@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon. Shri. Annasaheb Dange Ayurved Medical College and Post Graduate Reasearch Centre Ashta Tal Walwa Dist-Sangli Pin code 416301 |
|
|
Primary Sponsor
|
| Name |
Hon Shri Annasaheb Dange Ayurved Medical College and Post Graduate Reasearch Centre Ashta |
| Address |
Hon Shri Annasaheb Dange Ayurved Medical College and Post Graduate Reasearch Centre Ashta Ashta Tal Walwa Dist-Sangli Pin code 416301
Maharashtra
India |
| Type of Sponsor |
Private 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 |
| Nisha Baban Pawshe |
Dhanvantari Hospital Ashta |
Prasuti tantra Avum Stri roga
OPD Hon. Shri. Annasaheb Dange Ayurved Medical College and Post Graduate Reasearch Centre Ashta Tal -walva Dist- Sangli
Sangli
MAHARASHTRA |
9326954322
nishapawshe@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N719||Inflammatory disease of uterus, unspecified. Ayurveda Condition: IUCD Associated Excessive Bleeding, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Ibuprofen 400 mg | Tab Ibuprofen | | 2 | Comparator Arm (Non Ayurveda) | | - | Ibuprofen 400 mg | 1 Medicine Name:Tab Ibuprofen Reference: journal of reproductive Health & Contraception
Route:oral Dose form: Table, Dose 400 mg , Frequency:tds, Bhaishjaya kal(Time) After food, Duration:5days,sahalana:koshanjala
, Additional information:3 consecutive Menstrual Cycle | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rakata Punarnava, Reference: Raja Nighantu 1-5/155, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: -koshan jala), Additional Information: 3 consecutive Menstrual Cycle |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Age above 22 to 40 year.
Patient complaints abnormal uterine bleeding and abdominal pain after insertion of IUCD
Patient irrespective of Religion , social economic conditions caste occupation |
|
| ExclusionCriteria |
| Details |
Patient with any diagnosed uterine organic pathology like fibroid , adenomyosis or chronic tubo -ovarian mass .
Hb≤7 gm%
IUCD induced perforation.
Detective coagulation
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Rakta Punarnava in IUCD Associated Excessive Bleeding. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Rakta Punarnava and Ibuprofen in IUCD Associated Excessive Bleeding |
18 month |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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 2 |
|
Date of First Enrollment (India)
|
07/11/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The most common complications of IUCD is an increase menstrual blood loss and pain in cyclical period . In Ayurveda we can correlated this complications with vataja Rakta Pradar . |