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CTRI Number  CTRI/2020/01/022935 [Registered on: 24/01/2020] Trial Registered Prospectively
Last Modified On: 29/04/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   usage and benefits of Ayurveda medicines SOUBHAGYA SHUNTHI PAKA AND DASHAMULARISTA IN sutika (after delivery(Post natal period) 
Scientific Title of Study   CLINICAL EVALUATION OF THE EFFICACY OF SOUBHAGYA SHUNTHI PAKA AND DASAMOOLARISTA IN SUTIKA PARICHARYA (POST NATAL CARE) 
Trial Acronym  SPDA IN PNC 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrKPrameeladevi 
Designation  Research Officer (Ay) Scientist-3 
Affiliation  Dr.Achanta Lakshmipathi Research Centre for ayurveda,CCRAS,M/o of AYUSh,Govt.of India 
Address  Research Officer (Ay) Scientist-3 Dr.Achanta Lakshmipathi Research Centre for ayurveda, VHS Campus Hospital Taramani,Chennai

Chennai
TAMIL NADU
600113
India 
Phone  9445812604  
Fax    
Email  kprameel@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrKPrameeladevi 
Designation  Research Officer (Ay) Scientist-3 
Affiliation  Dr.Achanta Lakshmipathi Research Centre for ayurveda,CCRAS,M/o of AYUSh,Govt.of India 
Address  Research Officer (Ay) Scientist-3 Dr.Achanta Lakshmipathi Research Centre for ayurveda, VHS Campus Hospital Taramani,Chennai

Chennai
TAMIL NADU
600113
India 
Phone  9445812604  
Fax    
Email  kprameel@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrKPrameeladevi 
Designation  Research Officer (Ay) Scientist-3 
Affiliation  Dr.Achanta Lakshmipathi Research Centre for ayurveda,CCRAS,M/o of AYUSh,Govt.of India 
Address  Research Officer (Ay) Scientist-3 Dr.Achanta Lakshmipathi Research Centre for ayurveda, VHS Campus Hospital Taramani,Chennai

Chennai
TAMIL NADU
600113
India 
Phone  9445812604  
Fax    
Email  kprameel@gmail.com  
 
Source of Monetary or Material Support  
CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES MINISTRY OF AYUSH GOVT OF INDIA 
 
Primary Sponsor  
Name  CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES 
Address  Central Council for Research in Ayurvedic Sciences (CCRAS), Ministry of AYUSH, Government of India, JawaharLal Nehru BhartiyaChikitsaEvam Homoeopathy AnusandhanBhawan, 61- 65, Institutional Area, Opposite D Block, Janakpuri, New Delhi-110058, INDIA 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr KPrameeladevi  Dr Achanta Lakshmipathi Research centre for ayurveda   Dr Achanta Lakshmipathi Research centre for ayurveda VHS CAMPUS HOSPITAL CHENNAI
Chennai
TAMIL NADU 
9445812604

kprameel@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL EHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  to see the efficacy of Ayurvedic Drug interventions in postnatal mothers in increasesd quantity of milk involution of uterus pain abdomen 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1. Primipara / Multipara with non-complicated full term vaginal delivery,
2. Age between 20 – 35 years
3. Woman willing and able to participate in the study.
4. Woman in 3rdto 10thpostnatal day.
 
 
ExclusionCriteria 
Details  1. Woman who delivered by Caesarian section or forceps delivery/ vacuum application
2. Woman after 11thpostnatal day.
3. Puerperium associated with complications like severe postpartum haemorrhage, acute inversion of uterus, puerperal eclampsia, psychosis, postnatal gestational Diabetes
4. With uncontrolled hypertension (>160/100 mm of Hg).
5. With uncontrolled diabetes mellitus {HbA1c> 8.0 %.)
6. With evidence of malignancy.
6. Mothers with active herpes breast/breast abscess/retracted nipple/severely cracked nipples, having h/o of HbsAg+ve, HIV+ve, Tuberculosis, Chronic medical conditions.
7. Any other condition which the Principal Investigator thinks may jeopardize the study.
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To assess the clinical efficacy of Soubhagya Shunthi Paka and Dasamoolarishta in SutikaParicharya (w.s.r to postnatal care)  To assess the clinical efficacy of Soubhagya Shunthi Paka and Dashamularista in SutikaParicharya (w.s.r to postnatal care) 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the clinical efficacy of Soubhagya Shunthi Paka and Dashamularista in SutikaParicharya (w.s.r to postnatal care)
Improvement in Quality of life by the sustainable effect of Soubhagya Shunthi Paka and Dashamularista. 
3 MONTHS 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/01/2020 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 04/11/2021 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Under process 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

A postnatal period begins immediately after the separation of placenta and extending up to six weeks (this period varies as some Acharyas described up to 45days or up to 6 months after delivery)1, otherwise called as puerperium or puerperal period. The care given during this period is called as SutikaParicharya in Ayurveda. During the time of labour mother undergoes tremendous physical exertion and becomes extremely debilitated physically and mentally; which leads to derangement of Doshas especially Vatadosha in the mother. These pathological changes cause general weakness, pain abdomen, low back pain, loss of appetite, dysfunction of bladder, post-natal psychosis etc. Apart from these, mother also suffers with Dhatukshya. If this stage is unattended by appropriate measures then that will lead to maternal morbidity.

In order to reduce the postpartum maternal morbidity, reforming postpartum care measures by providing holistic and flexible maternal health care is necessary. The WHO suggested that maternal care should be de-medicalized, individualized, family-centered, multidisciplinary, holistic, and culturally appropriated.

In the existing modern medical system, puerperal care limits to supplementation of the iron, calcium and prevention of infections. Two major demands of Puerperium i.e. care for proper involution of genital organs and ensuring optimum lactation are still left un-addressed. Whereas in Ayurveda medicaments and procedures described for post-natal woman is culturally very much appropriate, is by and large comprehensive in serving all the demands of the pueperium. It is by far more scientific and helps in proper involution of the uterus, ensures optimum lactation, kindles digestive as well as metabolic fire, replenishes the lost Dhatu (tissue elements), prevents infections, helps to regain tone of urinary bladder and other smooth muscle

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organs like intestines, finally it ensures the uneventfullpueperium and complete growth of the baby.

Importance of This Work:

In the modern system of medicine supplementation of heamateanics, Calcium and Vitamins are available

for the management of Sutika Kala (post-natal phase). These medicines will take care of replenishment of

mineral and vitamins only. However the other demands of post-natal phase like strengthen of uterus and

urinary bladder, adequate quantity of breast milk and also improvement appetite as well as general well

being are not full filled with these treatments. These Ayurvedic formulations (SoubhagyaShunthiPaka and

Dashamularista) has been in use since ages, and has been found to be useful in treating Sutika (post-natal

women) and promoting the health. The present study is being undertaken to scientifically study and

validate the effect of this Ayurvedic formulation.

Drug Review

In the present study two popular and classical prescription of Ayurveda are taken up for validation namely Dashamularishta and SoubhagyaShunthiPaka.

1. SoubhagyaShunthiPaka (AFI-I, Vol-I, Page No-160-162)

This formulation is prescribed in Ayurvedic classics in the management of Sutika (Pueperal woman) and is also used by folks in different parts of Indian subcontinent. This formulation is very appropriate in catering the demands of the post natal phase like involution of uterine, achievement of optimum lactation, regaining of tone of urinary bladder, intestines etc. This drug is mentioned in Ayurvedic formulary of India, Volume-I, page number 160-162.

2. Dashamularista (AFI-I, vol-I, Page No-13-14; API-part-II, vol-II, Page No20-24)

Dashamularishta is the first line compound drug used in the management of Vata predominant disorders. Sutika phase is predominant of Vata; it gets aggravated during labour and same aggravation continues in the post natal phase also due to Dhatukshaya (tissue destruction and loss). Hence in the present study Dashamularishta is taken up for validation. Some studies are also carried out with this drug in Post natal care. This preparation is standardized and also mentioned in Ayurvedic Formulary of India-I, in volume-I, Page No-13-14; API-part-II, Vol-II, Page No20-24.

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Co-ordinating Centre:

 
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