| CTRI Number |
CTRI/2022/10/046184 [Registered on: 04/10/2022] Trial Registered Prospectively |
| Last Modified On: |
16/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical trial to study of Jyotishmatyadi churna and matra basti of Satpushpa tail in patients of Artavakshaya w.s.r. Oligo-Hypomenorhhea. |
|
Scientific Title of Study
|
A Comparative clinical study to evaluate the effect of Jyotishmatyadi churna alongwith Satpushpa taila Matra basti in the management of Artavakshaya wsr to Oligo-Hypomenorhhea |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gyan jyoti Chaudhary |
| Designation |
MS Ayurveda research scholar |
| Affiliation |
State Ayurvedic College and Hospital Lucknow UP |
| Address |
PG department of Prasuti tantra and Stri rog,State Ayurvedic college and hospital,Tulsidas Marg,Lucknow
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
9140798293 |
| Fax |
|
| Email |
singhjyoti1483@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shashi Sharma |
| Designation |
Reader, PG Department of Prasuti Tantra and Stri Rog |
| Affiliation |
State Ayurvedic College and Hospital, Lucknow |
| Address |
PG department of Prasuti tantra and Stri rog ,State Ayurvedic College and Hospital ,Tulsidas Marg,Lucknow
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
7068364242 |
| Fax |
|
| Email |
shashibedar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gyan jyoti Chaudhary |
| Designation |
MS Ayurveda research scholar |
| Affiliation |
State Ayurvedic College and Hospital, Lucknow |
| Address |
PG department of Prasuti tantra and Stri rog,State Ayurvedic College and Hospital,Tulsidas Marg,Lucknow
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
9140798293 |
| Fax |
|
| Email |
singhjyoti1483@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Ayurvedic College and Hospital Tulsidas Marg Lucknow 226004 |
|
|
Primary Sponsor
|
| Name |
State Ayurvedic College and Hospital Lucknow |
| Address |
State Ayurvedic College and Hospital Tulsidas Marg Lucknow UP |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Gyan jyoti Chaudhary |
State Ayurvedic College and Hospital Lucknow |
OPD No 1 Department of Prasuti Tantra and Stri Rog State Ayurvedic College and Hospital Tulsidas Marg Lucknow
Lucknow
UTTAR PRADESH |
9140798293
singhjyoti1483@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee State Ayurvedic College and Hospital Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N915||Oligomenorrhea, unspecified. Ayurveda Condition: ARTAVAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Jyotishmatyadi churna, Reference: yog ratnakar (yoni vyapad roganamchikitsa), Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Milk), Additional Information: 3 consecutive cycles(2 cycles with trial drug and one cycle drug free follow up)after clearance of menses. | | 2 | Comparator Arm | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Charak Samhita, Procedure details: Medication/Therapy will be given once in a day upto 9 days in one cycle after clearance of menses and same will be repeated in next cycle also.After that follow up will be done for 30 days. )
(1) Medicine Name: Satpushpa, Reference: Kashyap Samhita, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 18 Days |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1- Patients between the age group of 18-40 years.
2- patients fulfilling cardinal symptoms of Artavakshaya.
3- patients willing to participate in the study with proper written consent.
|
|
| ExclusionCriteria |
| Details |
1- patient having systemic diseases(HTN,TB,DM)
2- Thyroid disorder
3- Pregnant & lactating women
4- patient onOCPs,IUCD
5- Congenital anomalies of uterus or ovaries
6- Patient with any pelvic pathology or malignancy
7- PCOD
8- Hb% less than 10 gm |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1- To assess the efficacy of Jyotishmatyadi churna along with satpushpa taila Matra Basti inthe management of Artavakshaya.
2- To assess the efficacy of trial therapy on subjective parameters like interval between two cycle,duration of bleeding,amount of blood loss and pain during menstruation- assess with the help of VAS scale. |
3 consecutive cycle (2 cycle with trial drug and one cycle drug free follow up. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of trial therapy on subjective parameters like interval between two cycles,duration of bleeding,amount of blood loss and pain during Menstruation- assess with the help of VAS scale. |
3 consecutive cycles (2 cycles with trial drug and one cycle drug free follow up ). |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
10/10/2022 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is entitled as – “A comparative clinical
study to evaluate the effect Jyotishmatyadi churna
alongwith Satpushpa
taila Matra Basti in the management of Artavakshaya w.s.r.
Oligo-Hypomenorrheaâ€.
Objective of study – To compare the efficacy of
Jyotishmatyadi churna and Jyotishmatyadi churna
alongwith Satpushpa taila Matra Basti in the management of
Artavakshaya w.s.r. Oligo-Hypomenorrhea.
Type of study – Randomized comparative open clinical
trial.
Administration of trial therapy – Minimum 40 patient
having cardinal symptoms of Artavakshaya will
registered into groups.
Group A – Jyotishmatyadi churna ( 3 gm ) twice a day
with milk after meal ( after clearance of menses ).
Group B – Jyotishmatyadi churna ( 3 gm ) twice a day
with milk after milk and Satpushpa taila Matra
Basti ( 60 ml ) once in a day for 9 days ( after clearance
of menses ).
Duration of period – 3 consecutive cycles ( 2 cycles
with trial drug and one cycle drug free follow up ).
Therapy period – 2 consecutive cycles after clearance
of menses.
Follow up during treatment – On the clearance of each
menstrual cycle during the period of treatment.
Criteria for selection of patient -
Diagnostic criteria – Diagnosis will be based on the presence of any
one or more of the cardinal symptoms of Artavakshaya.
A.
Yathochitakala Adarshanam of Artava –
Menstrual cycle > 35 days
B.
Alpartavam –
1.
Duration of bleeding < 2 days
2.
Decrease in quantity of Bleeding
C.
Yoni Vedana
Inclusion criteria –
1. 1 . Patients between age group of 18 – 40 years.
2. 2 . Patients fulfilling the cardinal symptoms of
Artavakshaya.
3. 3 . Patients willing to participate in the study
with proper written consent.
Exclusion criteria –
1.
Patient having systemic disease (HTN, TB , DM )
2.
Thyroid disorder
3.
Pregnant and Lactating women
4.
Patient on 0CPs , IUCD
5.
Congenital anomalies of uterus or ovaries
6.
Patient with any pelvic pathology or malignancy
7.
PCOD
8.
Hb% less than 10 gm
Investigation – At the time of registration.
1.
Hb%
2.
ESR
3.
FBS
4.
LFT
5.
Thyroid profile
6.
USG – Pelvic region ( Endometrial thickness )
7.
UPT
Assessment criteria –
Assessment will be done on the basis of improvement in the sign and
symptoms
for the purpose. Subjective criteria –
1.
Interval between two cycles 2.
Duration of bleeding
3.
Amount of blood loss
4.
Pain during menstruation – assess with the help
of VAS scale |