| CTRI Number |
CTRI/2025/07/091599 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study to find the effect of lajjalu powder and indrayava powder in management of menorrhagia with special reference to modern aspect |
|
Scientific Title of Study
|
Comparative clinical trial to determine the effect of lajjalu churna and indrayava churna in management of 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 |
Gulnaj Sherkhan Pathan |
| Designation |
PG scholar |
| Affiliation |
SST Ayurved Mahavidyalaya, Sangamner. |
| Address |
Department of Stree roga avum prasuti tantra SSTAC,sangamner
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9881697053 |
| Fax |
|
| Email |
pathangulnaj313@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonal Wagh |
| Designation |
HOD Dept of Streeroga avum prasuti tantra |
| Affiliation |
SST Ayurved Mahavidyalaya, Sangamner |
| Address |
Department of Stree roga avum prasuti tantra SSTAC, sangamner
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9960212188 |
| Fax |
|
| Email |
sonaldere1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonal Wagh |
| Designation |
HOD Dept of Streeroga avum prasuti tantra |
| Affiliation |
SST Ayurved Mahavidyalaya, Sangamner |
| Address |
Department of Stree roga avum prasuti tantra SSTAC, sangamner
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9960212188 |
| Fax |
|
| Email |
sonaldere1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Stree roga avum prasuti tantra SSTAC Sangamner, Ahmadnagar (MH)422605, India |
|
|
Primary Sponsor
|
| Name |
Gulnaj Sherkhan Pathan |
| Address |
Dept of Stree roga avum prasuti tantra SSTAC Sangamner Ahmadnagar (MH)422605, India |
| Type of Sponsor |
Other [Own research study ] |
|
|
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 Gulnaj Sherkhan Pathan |
Sangam Sevabhavi trusts Ayurved Mahavidyalaya, Sangamner |
OPD Division,1st floor,Room no 1,Stree roga avum Prasuti tantra OPD
Ahmadnagar
MAHARASHTRA |
9881697053
pathangulnaj313@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee SSTAC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E289||Ovarian dysfunction, unspecified. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Lajjalu Churna , Reference: Bhavprakash purvkhand , Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: Koshna jala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Indrayava Churna , Reference: Bhavprakash purvkhand , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: Koshna jala ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1 Patients who will give informed written consent for study
2 patients having sign and symptoms of Raktapradara such as Raja ati pravrutti,Dirgha kala artava pravrutti,Vedna in shroni prushtha and Kukshi,Yonigat daha,Daurbalya,Angmard and Hemoglobin above 7gm/dl |
|
| ExclusionCriteria |
| Details |
1 k/c/o pelvic and uterine pathology like Uterine fibroid,Polyp, Pelvic inflammatory disease, Adenomyosis, Post menopausal bleeding, malignant and non malignant tumors
2 k/c/o Any significant chronic illness
3 k/c/o ectopic pregnancy, abortion
4 k/c/o Any external injury to reproductive track
5 patients with IUCD and on OCP pills
6 Patient taking Anti coagulation therapy and having any coagulant defects like Thrombocytopenic Purpura |
|
|
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 |
| Improvement in Menorrhagia |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in amount & duration of menstrual bleeding |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
08/08/2025 |
| 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
|
Menorrhagia can result in severe anemia. 58 percent reported a history of anemia.It is common problem among women in the reproductive age. Excessive menstrual blood loss interferes with the woman ’s physical, emotional, social and psychological quality of life. In India reported prevalence of menorrhagia is around 15.9%. Progestogens are the most commonly prescribed therapy for
menorrhagia. Heavy uterine bleeding is managed with medical therapy ,hormonal therapy, antifibrinolytic drugs etc.which have lots of side effects & if unsuccessful is followed by surgical intervention.Dilatation & Curettage is best temporary treatment with limited efficacy.High rate of complication of Hysterectomy as well as it is not suitable for younger patient and who wish to conceive further. Due to limitation of medical therapy as well as surgical therapy of modern science, it becomes a necessity of time to find out an effective harmless therapy to manage the condition. In day-to-day practice, Raktapradara is one of the most common disorders. There are only few studies on the prevalence of Raktapradara in women from our country. So, it is very necessary to do some effective work on this topic. Both drug Lajjalu Churna and Indrayava Churna easily available, cost effective, palatable, and having no side effects. Hence topic is selected as Comparative Clinical trial to determine the effect of Lajjalu Churna and Indrayava Churna in management of Raktapradara W.S.R. to Menorrhagia. |