| CTRI Number |
CTRI/2025/01/078985 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of RaktaPradarahara Yoga (Choorna) in Raktapradara W.S.R to Menorrhagia |
|
Scientific Title of Study
|
A Randomised Comparative clinical study to evaluate the efficacy of RaktaPradarahara Yoga (Churna) over Pushyanuga Churna in Raktapradara W.S.R 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 Preeti Santosh Autade |
| Designation |
Post Graduate Resident in Prasuti Tantra and Stree Roga |
| Affiliation |
Dr. N.A. MAGADUM AYURVEDIC MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTER, ANKALI-591213 |
| Address |
Department Of Prasuti Tantra and Stree roga
Dr. N.A. Magadum Ayurvedic Medical College, Hospital and Research Center, Ankali 591213
Belgaum
KARNATAKA
591213
India |
| Phone |
8830059350 |
| Fax |
|
| Email |
preetiautade29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepali Koli |
| Designation |
Assistanat Professor Department of Prasuti Tantra and Stree roga |
| Affiliation |
Dr. N.A. MAGADUM AYURVEDIC MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTER, ANKALI-591213 |
| Address |
Department of Prasuti Tantra and Stree roga
Dr. N.A. Magadum Ayurvedic Medical College, Hospital and Research Center, Ankali-591213
Belgaum
KARNATAKA
591213
India |
| Phone |
8975953456 |
| Fax |
|
| Email |
drdeepali5119@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepali Koli |
| Designation |
Assistanat Professor Department of Prasuti Tantra and Stree roga |
| Affiliation |
Dr. N.A. MAGADUM AYURVEDIC MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTER, ANKALI-591213 |
| Address |
Department of Prasuti Tantra and Stree roga
Dr. N.A. Magadum Ayurvedic Medical College, Hospital and Research Center, Ankali-591213
Belgaum
KARNATAKA
591213
India |
| Phone |
8975953456 |
| Fax |
|
| Email |
drdeepali5119@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. N.A. Magadum Ayurvedic Medical College,Hospital and Research Center, Ankali Tal- Chikodi Dist- Belgaum Karnataka-591213 |
|
|
Primary Sponsor
|
| Name |
Dr Preeti Autade |
| Address |
Dr. N.A. Magadum Ayurvedic Medical College, Hospital and Research Center, Ankali -591213 |
| 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 |
| Dr Preeti Santosh Autade |
Dr. N.A. Magadum Ayurvedic College, Hospital and Research Center Ankali |
Dr. N.A. Magadum Ayurvedic College, Hospital and Research Center Ankali 591213
Belgaum
KARNATAKA |
8830059350
preetiautade29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. NAMAMC-IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N920||Excessive and frequent menstruation with regular cycle. 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: Raktapradarahara Yoga (Choorna), Reference: Bhaisajya Ratnavali, Pradararogaadhikar(66/25-30), Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Sukhoshna Jala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Pushyanuga Choorna, Reference: Charak Chikitsa. 30/90-95, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Madhu and Tandoolodak), Additional Information: not applicable |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1) Patients complaining of excessive menstrual bleeding
a) Duration - More than 5 Days/21-35 days
b) Quantity - More than Grade 2 Bleeding according to Pictorial Blood Assesement
Scale (i.e. more than 3 pads per day).
2) Age between 15-40 years/ Married or Unmarried.
3) Patient excessive cyclic bleeding for atleast 3 consecutive cycles.
4) Patients with Acute and chronic Pelvic Inflammatory Disease.
5) Patients with Intra-Mural/Interstitial fibroids and Submucous fibroids. |
|
| ExclusionCriteria |
| Details |
1. Patients present with bleeding due to Abortion, Pregnancy and Lactation will be excluded.
2. Patient with systemic and endocrine disorder interfering with the present study will be
excluded like: Sexually Transmitted Diseases, Hyperthyroidism, Bleeding disorders,
Tuberculosis.
3. Patients having Hb percentage 8 gm% or less than 8 gm%.
4. Patients with Intra Uterine Contraceptive Device and patients taking Oral Contraceptive
Pills.
5. Patients taking Hormonal Replacement Therapy due to any cause.
6. Benign and malignant growth in the uterus.
7. Cases with pelvic pathology Ovarian Cyst, Endometriosis and Metorrhagia or
Menometorrhagia.
8. Patients acquired Cervical Stenosis, Vaginal Atresia will be excluded.
9. Patients with Submucousal Uterine fibroid, Cervical fibroids, Polyps. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reducing Excessive Menstrual Bleeding |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reducing other related symptoms like Adhoudar shoola and Katishula based on gradings given |
90 days |
|
Target Sample Size
Modification(s)
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/01/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The Present Study titled "A Randomised Comparative Clinical Study To Evaluate The Efficacy of Raktapradarahara Yoga (Choorna) over Pushyanuga Choorna in Raktapradara W.S.R. to Menorrhagia" will be conducted on 60 patients with 2 groups each group having 30 patients each with mentioned objective and subjective criteria. One group will be treated with Raktapradarahara Yoga(Choorna) and another with Pushyanuga Choorna, each for 90 days. Assessment of the patient will be done before treatment and after treatment. |