| CTRI Number |
CTRI/2019/12/022472 [Registered on: 20/12/2019] Trial Registered Prospectively |
| Last Modified On: |
26/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Effect Of Saubhagya Sunthi Granules in Sutika. |
|
Scientific Title of Study
|
Puerperal Care (Sutika Paricharya) Of Women Inhabiting Within Tribal Region Through Ayurvedic Herbal Formulation. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rahulkumar Ramkrushna Kamde |
| Designation |
Assistant Professor, PhD (Scholar) |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University), College of Ayurved, Pune-Satara Road, Pune-411043 |
| Address |
Department of Prasuti tantra & Stree rog,
2nd floor, New building Room No.128
College Of Ayurved, Bharti Vidyapeeth (Deemed to be University), Katraj, Pune (MS)
Pune
MAHARASHTRA
411043
India |
| Phone |
9422815205 |
| Fax |
|
| Email |
kamderahul77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahulkumar Ramkrushna Kamde |
| Designation |
Assistant Professor, PhD (Scholar) |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University), College of Ayurved, Pune-Satara Road, Pune-411043 |
| Address |
Department of Prasuti tantra & Stree rog,
Ground floor, OPD building Room No.1
KVTR Ayurved Corllege Boradi
Tal- Shirpur
Dhule
MAHARASHTRA
425428
India |
| Phone |
9422815205 |
| Fax |
|
| Email |
kamderahul77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati Surendra Mohite |
| Designation |
Professor & HOD (Prasuti tantra evum Striroga) |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University), College of Ayurved, Pune-Satara Road, Pune-411043 |
| Address |
Department of Prasuti tantra & Stree rog,
2nd floor, New building
Room No 128
College Of Ayurved, Bharti Vidyapeeth (Deemed to be University), Katraj, Pune (MS)
Pune
MAHARASHTRA
411043
India |
| Phone |
9822004562 |
| Fax |
|
| Email |
dr.ssmohite@gmail.com |
|
|
Source of Monetary or Material Support
|
| College Of Ayurved, Bharti vidyapeeth (Deemed to be University), Katraj, Pune (MS)- 411043 |
|
|
Primary Sponsor
|
| Name |
Dr Rahulkumar Ramkrushna Kamde |
| Address |
KVTR Ayurved College, Boradi, Tal: Shirpur, Dist: Dhule (MS)
Pin code: 425428 |
| Type of Sponsor |
Other [Private Ayurved Medical college & Hospital] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rahulkumar Ramkrushna Kamde |
College of Ayurved, Bharti Vidyapeeth |
Department of Prasuti tantra & Striroga, COA, BV(DU), Pune-Satara road, Katraj, Pune 411043
Pune
MAHARASHTRA |
9422815205
kamderahul77@gmail.com |
| Dr Rahulkumar Ramkrushna Kamde |
KVTR Ayurved College, Boradi |
At post- Boradi, Tal- Shirpur, Dist- Dhule 425428
Dhule
MAHARASHTRA |
9422815205
kamderahul77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Bharti Vidyapeeth(DU) College of Ayurved Ethics Committee |
Approved |
| Institutional Ethics committee, KVTR Ayurved College, Boradi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O909||Complication of the puerperium, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No Medicinal Intervention |
Tribal Patients will follow their traditional diet and routine |
| Intervention |
Saubhagya Sunthi Granules |
Saubhagya Sunthi Granules
5 gram BD Per Oral
From First to 42nd day Post natal |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Volunteers willing to participate as a clinical trial subject and giving written consent.
Age between 18 to 45 years.
Woman with uncomplicated vaginal delivery with or without episiotomy.
Woman with mild anemia Hb% 7 gm or more, will be included.
|
|
| ExclusionCriteria |
| Details |
Volunteers not willing to participate or not giving consent will be excluded.
Woman with serious post natal complications namely Severe PPH, Shock, Eclampsia, Uterine Inversion.
Severe anemia Hb% less than 7 gm.
Woman with known sensitivity or allergy to any of the ingredient(s) of the Study drug.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Effect of Study drug on Involution of Uterus, assessed by Symphysis Fundal Height (Day: 0-3; 10-14 post natal)
2)Effect on color and amount of lochia (Day: 0-3; 10-14; 24-28 post natal)sanitary pad examination.
3)Effect on After Pains (Day: 0-3; 10-14; 24-28; 41-45 post natal) assessed by VAS scale |
Day: 0-3; 10-14; 24-28; 41-45 post natal |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Effect on Lactation (Day: 0-3; 10-14; 24-28; 41-45 post natal) assessed by Neonatal weight gain, urine, stool & sleep pattern
2) Anti-inflammatory effect on wound; if present (Day: 0-3; 10-14; 24-28; 41-45 post natal)
3) Global assessment of Overall safety and tolerability of study drug by investigator and the subject at the end of trial.
|
Day: 0-3; 10-14; 24-28; 41-45 post natal |
|
|
Target Sample Size
|
Total Sample Size="800"
Sample Size from India="800"
Final Enrollment numbers achieved (Total)= "1071"
Final Enrollment numbers achieved (India)="1071" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
29/12/2019 |
| Date of Study Completion (India) |
29/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
1)WORLD JOURNAL OF PHARMACEUTICAL AND MEDICAL RESEARCH (ISSN:2455-3301) Vol6 Issue5. "THEORETICAL ESTABLISHMENT OF MAINENANCE OF HEALTH OF SUTIKA THROUGH BIOACTIVE INGREDIENTS OF SAUBHAGYA SUNTHI PAK" Manuscript no. WJPMR/3533/6/2020. SJIF impact factor: 5.922, ICV 78.6
2) THE JOURNAL OF ORIENTAL RESEARCH MADRAS
ISSN:0022-3301;
Vol. XCIII-XV: 2022,
November 2022
(P.No. 45-51)UGC CARE
Group-1:369
(Year 2022)
"SAUBHAGYA SUNTHI PAK- KEY TO HEALTH FOR NEW MOTHERS"
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is an open labeled, non-randomized, controlled clinical trial for assessment of efficacy and safety of Saubhagya Sunthi Granules in tribal women during puerperium. The sample population is from tribal region of district Dhule, Maharashtra, India. The primary outcome measure will be the effect on involution of uterus, color & amount of lochia and after pains of delivery. The secondary outcome measure will be the effect on lactation and anti-inflammatory effect assessed regularly on Day: 0-3; 10-14; 24-28; 41-45 post natal, as well as Global assessment of safety and efficacy by subjects and investigator at the end of trial. Due to Lockdown imposed in pandemic of COVID 19, Preperation of investigational product was abandoned. After conditions got better the trial is underway. Trial is open for recruitment since 18/10/2020. Present clinical trial was planned to reach out
such deprived population. Control group was the one which practiced their
traditionally practiced puerperal regimen {sutika paricharya (aahar &
vihar)} and experimental group was supplemented with Saubhagya Sunthi
Granules (SSG) along with traditionally practiced puerperal regimen {sutika
paricharya (aahar & vihar)}. A total 1071 subjects were
screened during Oct 2020 to May 2022. 196 met exclusion criteria, 875 included
to trial by alternate allocation in both groups. The number of subjects dropped
out from experimental and control group was 30 & 25 respectively.
Completers (400 from either groups) were evaluated statistically on the basis
of various demographic as well as subjective and objective parameters. The
quest was to find out effect of consumption of Saubhagya Sunthi Granules
(SSG) by puerpera (sutika). The results obtained were discussed in
comparison with available previous authentic research conclusions and
officially published records available on internet.
The
large sample size was adequate to reach authentic conclusions. The final
conclusions derived are as follows:
•
Consumption of SSG made a brisk and sustained positive
impact on digestive power of subjects in experimental group whereas in control
group the digestive power raised at a gradual physiological rate over a period
of 6 weeks postpartum. This demarcation between both groups is found
statistically significant.
•
Breast secretions (Lactation) in subjects of experimental
group shown more improvement, which is statistically significant.
•
Neonatal weight gain was evaluated more significant in
babies of subjects in experimental group. Thus indicating better quality and
quantity of breast milk in subjects of experimental group.
•
Neonatal urine output, stool output and sleep trajectories
was found better in babies of subjects in experimental group which is
conclusive of better amount of breast milk received.
Among laboratory parameters, statistically
significant rise in Hemoglobin% was noted in experimental group and reversal of
the Total Leucocyte Count to normal limits is found more effectively in
subjects of experimental group.•
The subjects in experimental groups has better reversal of
post-natal obese belly.
•
The subjects in experimental group has a lower rate of post
natal weight retention hence the BMI recorded was also inclined more towards
healthier limits.
•
Observed
percentage of improvement in after pains assessed by VAS scale, is almost
identical for both the groups. Hence SSG is not found much effective in post
natal after pains.
•
There was no statistically significant distinction observed
between the control and experimental groups concerning the recovery of the
perineal wound. But in control group 4 (3.39%) subjects reported with perineal
wound dehiscence and another 6 (5.08%) suffered from tender perineal scar.
Whereas in experimental group no such adverse event detected.
•
The vital parameters like temperature, pulse and blood
pressure were identical in both groups and mostly noted unaffected.
•
Blood sugar random were found within limits of normal. No significant
variation was observed in both groups.
•
There was no statistically significant distinction observed
between the control and experimental groups with respect to pattern &
amount of lochial discharge and relief from after pains.
The
conclusions are summarized as, major role of Saubhagya Sunthi Granules (SSG)
was assumed to aid for involution of genital organs, prevention of post-natal
ailments and facilitate lactation. All these actions are found affirmative in
the present clinical trial.
Consumption
of SSG during
puerperal stage has shown excellent effect on digestive power, lactation, enhanced
haemoglobin percentage, reversal of leucocytosis, neonatal weight gain, better
neonatal urine-stool output and better sleep trajectories of neonate.
Moderate efficacy of SSG is seen in reversal of
post natal obese belly, lower rate of post natal weight retention and healing
of perineal wound.No alteration was noted in
temperature, pulse, blood pressure, random blood sugar, pattern & amount of
lochia and after pains.
Good
to excellent
grades were awarded for Saubhagya Sunthi Granules on the Global
Assessment of overall safety & tolerability by the subjects in the
experimental group. |