| CTRI Number |
CTRI/2026/03/106162 [Registered on: 13/03/2026] Trial Registered Prospectively |
| Last Modified On: |
12/03/2026 |
| 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
|
Effectiveness of Two Ayurvedic Medicines (Sunthi-Lodhara and Lajjalu Churna) in Treating Heavy Periods |
|
Scientific Title of Study
|
Comparative clinical Trial to determine the effect of Shunthi-Lodhra Churna and Lajjalu 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 |
Dr Snehal Namdev Kakade |
| Designation |
Pg scholar |
| Affiliation |
SST Ayurved mahavidyalay, Sangamner |
| Address |
Department of stri rog evum prasuti tantra sangam sevabhavi trust Nashik, Pune road opposite Prasad cafe,Sangamner Ahmednagar maharashtra India 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
7028387428 |
| Fax |
|
| Email |
Snehalkakade165@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mangesh Moule |
| Designation |
Assistant professor |
| Affiliation |
SST Ayurved mahavidyalay, Sangamner |
| Address |
Department of stri rog evum prasuti tantra sangam sevabhavi trust Nashik, Pune road opposite Prasad cafe,Sangamner Ahmednagar maharashtra India 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
918485078771 |
| Fax |
|
| Email |
mangeshmoule@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mangesh Moule |
| Designation |
Assistant professor |
| Affiliation |
SST Ayurved mahavidyalay, Sangamner |
| Address |
Department of stri rog evum prasuti tantra sangam sevabhavi trust Nashik, Pune road opposite Prasad cafe,Sangamner Ahmednagar Maharashtra India 422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
918485078771 |
| Fax |
|
| Email |
mangeshmoule@gmail.com |
|
|
Source of Monetary or Material Support
|
| SST Ayurved mahavidyalay, Nashik Pune road, opposite to Prasad hotel, Sangamner District-Ahmednagar maharashtra India 422605 |
|
|
Primary Sponsor
|
| Name |
Dr Snehal Namdev Kakade |
| Address |
Department of stree rog evum prasuti tantra sangam sevabhavi trust nashik Pune road Sangamner district -Ahmednagar maharashtra India 422605 |
| Type of Sponsor |
Other [Self] |
|
|
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 Snehal Namdev Kakade |
SST Ayurved college |
OPD division 1st floor room number 1 streerog evum prasuti tantra OPD, SST Ayurved college Sangamner,Nashik Pune road,opposite Prasad hotel, Dist Ahmednagar
Ahmadnagar
MAHARASHTRA |
7028387428
Snehalkakade165@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: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: Lajjalu, Reference: Bhavprakash niganthu, madhyam khand,lajjalu varga, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: Koshna jal), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shunthi-Lodhara churna, Reference: Yogratnakar , pradar chikitsa, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2.5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: -Ghrut & Sharkara 2.5 GM each), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
1 Patients who will give informed written consent for study.
2 Patients of age group 18 to 49 years (reproductive age group).
3 The patients having clinical signs and symptoms of Raktapradara - Raja Ati Pravrutti (Excessive menstrual bleeding), Dirgha Kala Artava Pravrutti (Prolong menstrual bleeding more than 7 days), Vedana in Shroni Prushtha and Kukshi (Pain in the pelvic region), Yonigat Daha (Burning sensation in external genitalia), Daurbalya (Generalized Weakness), Angmard (Bodyache).
4 Hemoglobin percentage above 7 g/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, recent abortion, DUB.
4 K/C/O any external injury to reproductive track. Patients with IUCD and OCP pills.
• Patients 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 |
| Reduction in sign and symptoms of raktapradar such as raja aati pravrutti, Dirgha kala artava pravrutti, vedana in shroni, prushtha,kakshi,yonigat daha. |
Duration of study- 18 months
Duration of treatment- 12 weeks
Follow up - 2nd, 4th week of 3 consecutive menstrual cycles(12weeks). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
26/03/2026 |
| 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
|
Title- Comparative clinical trial to determine the effect of Shunthi-Lodhra Churna and Lajjalu Churna in management of Raktapradar(Menorrhagia).
Introduction- Raktapradar means excessive menstrual bleeding in Ayurveda. Correlated with Menorrhagia (bleeding more than 80 ml or less than 7 days). Caused due to Vata-Pitta dosha vitiation. Raktapradar have Symptoms like excessive bleeding, weakness, pain, burning sensation. Menorrhagia prevalence in India is15.9 percentage. Modern treatment (hormonal therapy, antifibrinolytics) have side effects like nausea, vomiting, weight gain. Surgical options (D&C, hysterectomy) is not suitable for young women. Ayurvedic drugs are safe, economical, and effective.
Hypothesis- Null hypothesis (H0): No significant difference between both drugs.
Alternative hypothesis (H1): Significant difference exists.
Primary objective- Compare effectiveness of both drugs in reducing menstrual bleeding quantity and duration.
Secondary objectives- Assess improvement in:Pain,Weakness,Irritability.
Study design- Type of study is Open label comparative clinical study. Study duration is18 months.Treatment duration is12 weeks.
Sample size-Total sample size for study will be 80 participants divided equally between two groups. |