| CTRI Number |
CTRI/2024/11/076982 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
18/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect Of Dhatryadi Ghanvati IN Adolscent Female Having Heavy Menstrual Bleeding |
|
Scientific Title of Study
|
A Randomized Open Controlled Clinical Trail To Assess The Add on Effect of Dhatryadi Ghanvati in Taruni Asrugdar W.S.R. to Puberty Menorrhagia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sayali Uttam Bhosale |
| Designation |
PG Scholar Pre Ms Striroga and Prasutitantra |
| Affiliation |
Yashwant Ayurvedic College P.G. Training And Research Centre |
| Address |
Yashwant Ayurvedic College P.G. Training And Research Centre Striroga and Prasutitantra Department OPD No. 8,15 and IPD No. 26, Kodoli Tal Panhala Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7710937193 |
| Fax |
|
| Email |
sayalibhosale86@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sayali Uttam Bhosale |
| Designation |
PG Scholar Pre Ms Striroga and Prasutitantra |
| Affiliation |
Yashwant Ayurvedic College P.G. Training And Research Centre |
| Address |
Yashwant Ayurvedic College P.G. Training And Research Centre Striroga and Prasutitantra Department OPD No. 8,15 and IPD No. 26, Kodoli Tal Panhala Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7710937193 |
| Fax |
|
| Email |
sayalibhosale86@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishala Turlapati |
| Designation |
PG Guide Professor Streeroga and Prasutitantra Department |
| Affiliation |
Yashwant Ayurvedic College P.G. Training And Research Centre |
| Address |
Yashwant Ayurvedic College P.G. Training And Research Centre Striroga and Prasutitantra Department OPD No. 8,15 and IPD No. 26, Kodoli Tal Panhala Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9960217429 |
| Fax |
|
| Email |
vishalaturlapati@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic Medical College P.G. Training and Research Centre Kodoli Tal Panhala District Kolhapur 416114 ,Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Sayali Uttam Bhosale |
| Address |
Yashwant Ayurvedic Medical College P.G. Training and Research Centre Kodoli Tal Panhala District Kolhapur416114,
Maharashtra ,India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sayali Uttam Bhosale |
Yashwant Ayurvedic College P.G. Training And Research Centre |
Striroga and Prasutitantra Department OPD No. 8,15 and IPD No. 26, Kodoli Tal Panhala Dist Kolhapur 416114
Kolhapur
MAHARASHTRA |
7710937193
sayalibhosale86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BORS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N922||Excessive menstruation at puberty. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dhatryadi Ghanvati , Reference: Bhaishajya Ratnavali 66/17, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Jal), Additional Information: -Dhatryadi Ghanvati Orally in Dose of 2 Ratti i.e. 250mg 2 tablets with water before meal Twice a Day along with Rest Reassurance and Ferrous Ascorbate Orally in Dose of 100 mg Once a Day | | 2 | Comparator Arm (Non Ayurveda) | | - | Rest Reassurance and Hematinics ( Ferrous Ascorbate 100mg) | Rest Reassurance and Hematinics ( Ferrous Ascorbate 100mg) orally Once a Day |
|
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients with Irregular or Prolonged cycle more than 7 days and excessive bleeding per vagina i.e. use more than 5 pads in 24 hours during Menstruation
2.Polymenorrhagia
3.Intermenstrual Bleeding ( Anruta Artava- Chakradatta)
4. Patient with Hb 7g/dl or more than 7g/dl
5.Patient with BMI between 18-28
6.Patients with Pittaj and Vataj Asrugdar Lakshanas |
|
| ExclusionCriteria |
| Details |
1. K/C/O Endocranial Disorder like Hypothyroidism Hyperthyroidism PCOS
2. K/C/O Bleeding Dyscrasias
3. K/C/O Structural Abnormalities in Genital Organ
4. K/C/O Systemic Disorder |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce Duration and Amount of Bleeding During Menstruation and Regulate the Menstrual Cycle |
To achieve the Outcome in 90 days
Follow up in every month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduce Duration and Amount of Bleeding During Menstruation to Prevent Further progress of Administration of Hormones.
To Achieve the Control on Excessive Bleeding |
90 days |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/12/2024 |
| 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="1"
Months="0"
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
|
Puberty Menorrhagia is a problem of concern for growing female from Adolescence to Reproductive Age with depletion of iron because of menorrhagia , needs to be addressed with alternative methods against administration of steroidal hormones, hence Dhatryadi Ghanavati is selected for topic of Research and Ayurveda Basic Concept insist on Ahar, Vihar and Pathya Apathya . Dhatryadi Ghanavati has Rasayna properties which plays role in dhatu vardhana as well as have hemostatic properties which control excessive bleeding . |