| CTRI Number |
CTRI/2025/03/081612 [Registered on: 04/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Curative] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing the effect of Nagakeshara and Surpunnaga for change in symptoms of Abnormal Uterine Bleeding in 60 women participants. |
|
Scientific Title of Study
|
A Randomised Comparative Clinical Study To Evaluate The Efficacy Of Nagakeshara(Messua Ferrae Linn. ) And Its Market Substitute Surpunnaga(Ochrocarpus Longifolius Benth and Hook) In The Management Of Asragdara Wsr To Abnormal Uterine Bleeding. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Disha Parmar |
| Designation |
PG Scholar |
| Affiliation |
National Institute Of Ayurved |
| Address |
Department of Dravyaguna, National Institute of Ayurveda, jaipur 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
7400308016 |
| Fax |
|
| Email |
drdishaparmar1812@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sumit Nathani |
| Designation |
Associate Professor |
| Affiliation |
National Institute Of Ayurved |
| Address |
Department of Dravyaguna, National Institute of Ayurveda, jaipur 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
7665809886 |
| Fax |
|
| Email |
sumitnathani24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Disha Parmar |
| Designation |
PG Scholar |
| Affiliation |
National Institute Of Ayurved |
| Address |
Department of Dravyaguna, National Institute of Ayurveda, jaipur 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
7400308016 |
| Fax |
|
| Email |
drdishaparmar1812@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Ayurveda Madhav Vilas Palace, Amer Rd, Jaipur, Rajasthan 302002 |
|
|
Primary Sponsor
|
| Name |
National Institute Of Ayurveda |
| Address |
Department Of Dravyaguna National Institute Of Ayurveda Jaipur 302002 |
| Type of Sponsor |
Government 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 Disha Parmar |
National Institute Of Ayurveda |
OPD No 26 27 19 National Institute Of Ayurveda Jaipur 302002
Jaipur
RAJASTHAN |
7400308016
drdishaparmar1812@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee National Institute Of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N939||Abnormal uterine and vaginal bleeding, 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: Nagakeshara, Reference: vangasena, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -sharkara and jala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: surpunnaga, Reference: nighantu adarsh, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -sharkara and jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Subjects gave the complaint of Asragdara with any two of the following features for 2 consecutive cycles. Heavy menstrual bleeding (amount Greater than 80ml) (Amount more than 80 ml will be assessed by pictorial blood loss assessment chart scoring more than 100 points.) Prolonged menstrual bleeding Greater than 7 days. Inter menstrual bleeding with/without heavy flow or Frequent menstrual cycle less than 24days. Features different from normal menstrual blood, pain, burning sensation, body ache. |
|
| ExclusionCriteria |
| Details |
Patients with chronic of systemic illness (Congestive cardiac failure, Hypertension, cirrhosis of liver, Tuberculosis endometritis, severe anemia, chronic renal disease, Insulin dependent diabetes mellitus etc.). Patients using Intrauterine contraceptive device or oral contraceptive pills (latrogenic). Patients with uterine and pelvic pathology (Fibroid size Greater than 2 cm, endometriosis, adenomyosis, polyp, high grade cervical erosion, endometrial thickness Greater than 20mm etc.). Benign and malignant growth. Thyroid dysfunction (endocrinal disorders). Patients having bleeding due to abortion, ectopic pregnancy, during puerperium. Patients taking Anti-coagulation therapy and having hematological disorders (Leukemia, Thrombocytopenic Purpura). Postmenopausal bleeding. Sexually transmitted infections/Genital tract infections. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in symptoms of Asragdara |
Change in the symptoms of Asragdara from baseline to 2 months of period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in PBLAC scoring system. |
Changes in PBLAC scoring system from baseline to 2 months of period. |
|
|
Target Sample Size
|
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 2 |
|
Date of First Enrollment (India)
|
20/03/2025 |
| 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
|
Due to scarcity and unavailability of Nagakeshara and
lack of awareness, fresh stamens and buds of other plants are used instead of Nagakeshara
stamens. Nagakeshara
is being substituted by Surpunnaga in
the market. This study aims at the
comparative evaluation of Raktastambhana
karma of Surpunnaga with Nagakeshara
and hence to prove its effect in asragdara
clinically. Aim: To compare
the efficacy of Nagakeshara and its market substitute Surpunnaga in the management of asragdara wsr to abnormal uterine
bleeding. Objectives: 1. Pharmacognostical and phytochemical evaluation of
Nagakeshara and its Market substitute
Surpunnaga. 2. To compare the efficacy of Nagakeshara and its Market substitute Surpunnaga on the Management of symptoms of Asragdara.
3. To compare the efficacy of Nagakeshara and its Market substitute Surpunnaga on the Management of scale of PBLAC scoring system. Null Hypothesis [Ho]-There is no
difference in the efficacy of Nagakeshara
and its Market substitute Surpunnaga
in the Management of asragdara. Alternative
Hypothesis [HA] – There is a difference in the efficacy of Nagakeshara and its Market substitute Surpunnaga in the Management of asragdara. Study Design : Study type : Interventional , A Single blind
Randomised comparative clinical study. Phase
of clinical trial : phase 2 , Sample size: 60 patients will be registered and they will be divided
into group A and
group B. Each
group will have 30 patients, Study duration: 18 months. The statistical analysis of the research will be
done using the appropriate statistical tests and with a significance level of
<0.05 and 80% statistical power. |