| CTRI Number |
CTRI/2025/08/092554 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of oral administration of shalmali ghrita in Raktapradara that is heavy menstrual bleeding |
|
Scientific Title of Study
|
Open randomized controlled clinical trial of Shalmali Ghrita in Raktapradara with special reference to 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 |
Dr Shital Dattrao Budhwant |
| Designation |
PG Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta |
| Address |
OPD No 6 Strirog And Prasuti Tantra OPD Ground Floor Dhanvantari Ayurved Hospital, Ashta Tal Walwa Dist Sangli OPD No 6 Strirog And Prasuti Tantra OPD Ground Floor Dhanvantari Ayurved Hospital, Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9284512575 |
| Fax |
|
| Email |
sdbudhawant111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Radha Phadnis |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta |
| Address |
3rd Floor Department Of Strirog And Prasuti Tantra Hon Shri
Annasaheb Dange Ayurved Medica College Post Graduate and
Research Center Ashta Tal Walwa Dist Sangli
Center Ashta Tal Walwa Dist Sangli Maharashtra 416301
Sangli
MAHARASHTRA
416301
India |
| Phone |
9545114545 |
| Fax |
|
| Email |
radhakulkarni6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Radha Phadnis |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Center Ashta |
| Address |
3rd Floor Department Of Strirog And Prasuti Tantra Hon Shri
Annasaheb Dange Ayurved Medica College Post Graduate and
Research Center Ashta Tal Walwa Dist Sangli
Center Ashta Tal Walwa Dist Sangli Maharashtra 416301
Sangli
MAHARASHTRA
416301
India |
| Phone |
9545114545 |
| Fax |
|
| Email |
radhakulkarni6@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange ayurved Medical College Post Graduate and Research Center
Ashta Tal Walwa Dist Sangli Maharashtra India 416301 |
|
|
Primary Sponsor
|
| Name |
Dr Shital Dattrao Budhwant |
| Address |
OPD no 6 Strirog And Prasuti Tantra OPD Ground Floor Dhanvantari
Ayurved Hospital Ashta Tal Walwa Dist Sangli |
| Type of Sponsor |
Other [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 |
| Dr Shital Dattrao Budhwant |
Hon Shri Annasaheb Dange ayurved Medical College Post Graduate and Research Center Ashta |
3rd Floor Department Of Streerog And Prasutitantra Hon Shri Annasaheb
Dange ayurved Medical
College Post Graduate
and Research Center
Ashta Tal Walwa Dist
Sangli
Sangli
MAHARASHTRA |
09284512575
sdbudhawant111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee Of Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate And Research Center Ashta Sangl |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N938||Other specified abnormal uterine and vaginal bleeding. Ayurveda Condition: RAKTAYONIROGAH/ASRUJA/APRAJA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shalmali Ghrita , Reference: Yogaratnakar Pradar Adhyay , Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | Drug | Other than Classical | | (1) Medicine Name: Combined oral contraceptive pills , Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 0.18(mg), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - | | 3 | Comparator Arm (Non Ayurveda) | Drug | - | | |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Women with age group 21 to 40 yrs.
2.Patient having heavy menstruation with prolonged bleeding (more than 7 days)
3.Excessive bleeding for atleast 2 consecutive cycle
4.Patient having regular menstrual cycle
5.Patient having HB more than 7gm % |
|
| ExclusionCriteria |
| Details |
1.Pregnancy
2.Congenital anamolies of genital tract
3.Patients undergoing treatment for any other illness.
4.Malignancy
5.Bleeding disorders
6.Patient with IUCD or on any other hormonal therapy
7.Systemic causes-uncontrolled hypertension, diabetes
8.Infections like STD
9.Patient with uterine Fibroid of size more than 4cm and more than 3 in number |
|
|
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 Shalmali Ghrita in management of Raktapradar |
90 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To review the ayurvedic concept of Raktapradar
To review the concept of
menorrhagia according to modern science
To access any untoward effect of Shalmali Ghrita |
90 Days |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
25/08/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
An exhaustive description of gynaecological diseases is mentioned in Ayurveda. The sign and symptom of abnormal excessive vaginal bleeding is given the term Asrugdara. Asrugdara literally means Dirana (excessive release) of Asrik (menstrual blood). Another term Raktapradara is also used which signifies Pradirana (excessive discharge) of Rakta or Rajah (menstrual blood). Aacharya Charaka described Asrugdara as a separate disease along with its management in Yonivyapad Chikitsa Adhyaya.Raktapradar comprises of pradiran which means excessive menstrual blood loss and prolonged menstruation. Cyclic regular menstrual bleeding which is excessive in amount & duration and volume. considered as Menorrhagia. Raktapradar can be correlated with menorrhagia. Abnormal uterine bleeding (AUB) is a broad term that describes irregularities in the menstrual cycle involving frequency, regularity, duration, and volume The treatment protocol for Raktapradar according to Ayurveda is based on correction of pitta dosha anubandhi vata dosha along with Rakta dhatu vata dosha is root cause of all the yoni dushti.Prevalance of Abnormal Uterine Bleeding is 17.09% |