| CTRI Number |
CTRI/2024/11/076921 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
04/11/2024 |
| 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 Boswellia serrata Roxb. (Twak and Niryas) on Atyartava (Excessive Menstural Bleeding) |
|
Scientific Title of Study
|
A COMPARATIVE STUDY OF SHALLAKI (BOSWELLIA SERRATA ROXB.) TWAK AND NIRYAS W.S.R. TO RAKTAPRADAR. |
| 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 Pragya Mandloi |
| Designation |
M.D. Scholar, Dravyaguna |
| Affiliation |
Pt. Khushilal Sharma Ayu. College Bhopal M.P. |
| Address |
Room No.226, PG Department Of Dravyaguna, Pt. Khushilal Sharma Government Autonomus Ayurveda College and Institute, Science Hills Behind MANIT, Bhopal, Madhya Pradesh, India, 462003
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9669048969 |
| Fax |
|
| Email |
mandloipragya43@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinod Sharma |
| Designation |
Reader Dravyaguna |
| Affiliation |
Pt. Khushilal Sharma Ayu. College Bhopal M.P. |
| Address |
Room No.226, PG Department Of Dravyaguna, Pt. Khushilal Sharma Government Autonomus Ayurveda College and Institute, Science Hills Behind MANIT, Bhopal, Madhya Pradesh, India, 462003
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9926379195 |
| Fax |
|
| Email |
Sharmavinod389@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pragya Mandloi |
| Designation |
M.D. Scholar, Dravyaguna |
| Affiliation |
Pt. Khushilal Sharma Ayu. College Bhopal M.P. |
| Address |
Room No.226, PG Department Of Dravyaguna, Pt. Khushilal Sharma Government Autonomus Ayurveda College and Institute, Science Hills Behind MANIT, Bhopal, Madhya Pradesh, India, 462003
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9669048969 |
| Fax |
|
| Email |
mandloipragya43@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. Khushilal Sharma Government Autonomus Ayurveda College and Institute, Bhopal |
|
|
Primary Sponsor
|
| Name |
Pt. Khushilal Sharma Ayu. College Bhopal M.P. |
| Address |
Pt. Khushilal Sharma Government Autonomus Ayurveda College and Institute, Science Hills Behind MANIT, Bhopal, Madhya Pradesh, India, 462003 |
| Type of Sponsor |
Other [State Government Ayurveda College and Institute] |
|
|
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 Pragya Mandloi |
Pt. Khushilal Sharma Government Autonomus Ayurveda College and Institute, Bhopal |
Opd No.12, Department of Prasuti Tantra and Striroga, Hospital Pt. Khushilal Sharma Government Autonomus Ayurveda College and Institute, Bhopal
Bhopal
MADHYA PRADESH |
09669048969
mandloipragya43@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee, Pt. Khushilal Sharma Government Autonomus Ayurveda College and Institute, Bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N921||Excessive and frequent menstruation with irregular cycle. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shallaki twak - Boswellia serrata, Reference: Dhanwantari nighantu, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shallaki Niryas- Boswellia serrata, Reference: Dhanwantari nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Age between Menarche and Menopause
2. Excessive bleeding during menstruation (change of more than 3 soiled pads/day)
3. Passing of large clots.
4. Prolonged Menstrual bleeding (more than 7 days)
5. Excessive bleeding for more than 2 consecutive cycles
6. Intermenstrual Bleeding
|
|
| ExclusionCriteria |
| Details |
1. Intrauterine growth such as Myomas, endometrial polyp etc.
2. Cancer of cervix and or uterus.
3. Hb less than 6 gm %.
4. Any other systemic disorders likely to influence menstrual cycle.
5. Case undergoing treatment for any other serious illness.
6. Woman using an IUCD/ OCP/depot.
7. Venereal disease.
8. Systemic cause mentioned below will also be kept under exclusion criteria:
Severe hypertension,Liver dysfunction,Congestive cardiac failure,Patient having bulky uterus, Patients having bleeding from sites other than uterus,Patients having coagulation disorder |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvment in subjective parameter of menorrhagia as-
1. Bleeding amount in no. of pads
2. Duration of flow or menstrual period (In no. of days)
3. Interval of Menstruation (in no. of days)
4. Pallor (Panduta) (Hb %)
5. Pain (Pain in abdomen / backache)
6. Weakness (Daurabalya)
7. Burning Sensation (Daha)
|
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Investigation:
Blood: Hb%, TLC, DLC, ESR, CT, BT |
30 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
02/12/2024 |
| 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
|
Aim of the study is to provide a simple, safe and herbal drug for patient of Raktapradar and Evaluation of efficacy of Shallaki niryas (Kunduru) and Shallaki twak
kwath. Participants fulfilling the inclusion criteria will be selected. Those patients will be selected, who fulfils the criteria of selection and
attended the OPD of department of Prasuti tantra and strirog at Pt. Khushilal
Sharma Govt. (Auto.) Ayurveda College and Institute Bhopal. The clinical trial will be taken out on 60 (30 Participants in each
group) and they were randomly selected and divided into 2 groups: Group A- Study group Group B- Study group CRITERIA FOR DIAGNOSIS 1. Patient presenting with complains of excessive and irregular menstrual
bleeding was selected. 2. Including symptoms: Angamarda, vedana, dourbalya, bhrama, murcha,
tama, daha, pralap, panduta, tandra, vataj rog. Assessment criteria:
Subjective parameters will be scored as mentioned in specially designed scale and
will be compared before and after treatment. Objective parameter will also be
compared at the same interval. The assessment criteria for Raktapradar will be
mainly based on: [a] Subjective criteria:
1. Bleeding amount in no. of pads 2. Duration of flow or menstrual period (In no. of days) 3. Interval of Menstruation (in no. of days) 4. Pallor (Panduta) (Hb %) 5. Pain (Pain in abdomen / backache) 6. Weakness (Daurabalya) 7. Burning Sensation (Daha) [b]. Objective criteria: Haemoglobin Level (Hb% Level) Investigation:
Blood: Hb%, TLC, DLC, ESR, CT, BT |